Podcasts about GMP

Episode 2769 - Vinnie Tortorich and Anna Vocino discuss trusting product certifications as well as make some fun announcements. https://vinnietortorich.com/2026/03/trusting-product-certifications-episode-2769 PLEASE SUPPORT OUR SPONSORS Pure Vitamin Club Pure Coffee Club NSNG® Foods VILLA CAPPELLI EAT HAPPY KITCHEN YOU CAN WATCH THIS EPISODE ON YOUTUBE - @FitnessConfidential Podcast Vinnie's workout videos are available to purchase! Choose from a 2-day, 4-day, or 6-day workout–or buy all three at a discount! TO PURCHASE VINNIE'S WORKOUT VIDEOS, CLICK THIS LINK: https://vinnietortorich.com/workout Trusting Product Certifications Anna was just on the Mike Rowe podcast, "The Way I Heard It". (2:00) Vinnie is excited about his guest, D-D Breaux, who is a legendary gymnastics coach. (7:00) D-D's episode has already been posted so that you can enjoy it sooner. You can listen to it here: https://sites.libsyn.com/40024/building-excellence-with-d-d-breaux-episode-2768 Vinnie wants to be back into skiing for the first time in nine years! (13:00) Anna received her Jaspr air scrubber. (22:00) Certification of products—what is that about, and is it real? (32:00) Anna explains how it works, and they discuss olive oil as an example. Compliance and scaling up manufacturing needs are important. Vinnie won't work with a company unless it is GMP- and NSF-certified. GMP is Good Manufacturing Practices. NSF is the National Science Foundation. Supplements can be suspect if they are manufactured in a facility without GMP or NSF practices. Certifications can matter and can also be abused. (48:00) Anna has a fantastic announcement: she is stepping into the shoes of the late Estelle Harris and becoming the voice of Mrs. Potato Head in Toy Story 5! (50:00) They discuss a little of the darker side of being an actor in L.A. (1:00:00) Did you miss it?: The NSNG® VIP group closed, but you can get onto the waitlist for next time by signing up at https://www.nsngvip.com/join. A New Sponsor Jaspr Air Scrubbers has a discount code, VINNIE, that gets you $300 off for a limited time. Jaspr offers a lifetime warranty. Go to Jaspr.co for more information or to purchase. (1:05:00) You can book a consultation with Vinnie to get guidance on your goals. https://vinnietortorich.com/phone-consultation-2/ More News Serena has added some of her clothing suggestions and beauty product suggestions to Vinnie's Amazon Recommended Products link. Self Care, Beauty, and Grooming Products that Actually Work! https://www.amazon.com/shop/vinnietortorich/list/3GPVU29UHHPMY?ref_=aipsflist Don't forget to check out Serena Scott Thomas on Days of Our Lives on the Peacock channel. "Dirty Keto" is available on Amazon! You can purchase or rent it here.https://amzn.to/4d9agj1 Please make sure to watch, rate, and review it! Eat Happy Italian, Anna's next cookbook, is available! You can go to https://eathappyitalian.com You can order it from Vinnie's Book Club. https://amzn.to/3ucIXm Anna's recipes are in her cookbooks, on her website, and on Substack —they will spice up your day! https://annavocino.substack.com/ PURCHASE DIRTY KETO (2024) The documentary launched in August 2024! Order it TODAY! This is Vinnie's fourth documentary in just over five years. Visit my new Documentaries HQ to find my films everywhere: https://vinnietortorich.com/documentaries Then, please share my fact-based, health-focused documentary series with your friends and family. Additionally, the more views it receives, the better it ranks, so please watch it again with a new friend! REVIEWS: Please submit your REVIEW after you watch my films. Your positive REVIEW does matter! PURCHASE BEYOND IMPOSSIBLE (2022) Visit my new Documentaries HQ to find my films everywhere: https://vinnietortorich.com/documentaries FAT: A DOCUMENTARY 2 (2021) Visit my new Documentaries HQ to find my films everywhere: https://vinnietortorich.com/documentaries FAT: A DOCUMENTARY (2019) Visit my new Documentaries HQ to find my films everywhere: https://vinnietortorich.com/documentaries

What if the reason you’re not healing isn’t that you need another diagnosis? 0:08 It’s that your cells aren’t receiving the right signals. Because the body doesn’t run on diagnosis, it runs on 0:16 communication. And peptides are one of the most powerful, most misunderstood 0:21 tools we have for cellular signaling, immune balance, tissue repair, gut 0:27 lining support, metabolic control, brain signaling, sleep cycles, and even sexual 0:35 wellness. Today, I’m going to do what most people won’t. Define peptides in 0:41 plain English for you. break them into categories by what they’re best at and 0:47 tell you which ones are FDA approved on the list and which ones are commonly 0:53 used off label or investigational with the evidence that actually says these 1:00 work. This is going to be a powerful episode and if you’ve ever felt like you’re hearing hype without clarity, 1:07 this one’s for you. So, as usual, grab your cup of coffee or tea and settle in 1:13 as we talk about peptides that can fit into your healing journey. We’re going 1:19 to have a short word from our sponsor. You know, we got to do that. That’s how we stay on the air here. So, we will be 1:26 right back after this. Did you know sweating can literally heal your cells? 1:32I nfrared saunas don’t just relax you. They detox your body, balance hormones, 1:37 and boost mitochondrial energy. I’m obsessed with my health tech sauna. And 1:42 right now, you can save $500 with my code at healthtechalth.com/drmuthqen25. 1:54 All right, here we go, guys. I am excited to dive into peptides with you. 2:00 So understanding peptides is foundational, right? And I’ve been 2:06 studying peptides now for about nine years. Um, and I find that they are 2:13 incredible. Um, so I want to break down for you what peptides actually are, what 2:19 they do, and some of the top peptides that are available today, and how they 2:25 can be utilized. Because I think it’s really important. And I think it’s it’s there’s a lot of confusion out there about what these things actually are and 2:32 are they safe? Are they not? When do we use them? What’s the science behind them? So, we’re going to dive in and 2:38 we’re going to talk about all things peptides. So, let’s get ready here. Here we go. So, peptides are short chains of 2:45 amino acids and they typically range anywhere from 2 to 50 amino acids and 2:51 they’re linked by peptide bonds. So think of them as the superglue that holds the amino acids together. They sit 2:58 between the amino acids and they are full proteins in terms of their size and 3:04 their complex structure. And what makes peptides particularly interesting in 3:10 medicine is their role as signaling molecules. They’re essentially the 3:15 body’s text messages carrying specific instructions to cells and tissues. And 3:21 unlike our proteins which often serve as structural roles or act as enzymes, 3:28 peptides typically function as hormones, neurotransmitters and growth factors and 3:33 they bind to specific receptors on the cell’s surfaces or within the cells and 3:39 they trigger this effect. It’s like a cascade effect of a biochemical reaction 3:45 that ultimately changes the cellular behavior. So basically, it’s changing 3:50 the way the body’s cell structure acts. And this is why peptides can be so 3:56 incredibly powerful and therapeutic when you introduce the right peptide signal. 4:02 Now, you could theoretically redirect cellular processes toward healing, 4:07 towards metabolism, immune balance, tissue repair. Any of those things can 4:14 be manipulated to do a certain thing once we add the peptide. The challenge 4:19 in peptide medicine though lies in distinguishing between those peptides that have been rigorously studied, 4:26 proven safe and effective and approved by regulatory bodies like the FDA versus 4:31 those that exist in what we call the gray zone of a promising clinical data. 4:36 But they really lack human validation so far. And this distinction is critical because the presence of a plausible 4:43 mechanism does not guarantee safety or efficacy in living humans. So, this is 4:50 really important and we’re going to dive in and look at some of the research on all of these different peptides that are 4:56 available and I’m excited to say there’s some amazing peptides being studied right now that unfortunately are not 5:01 available. But I can’t wait to see them hit the market for us because it is going to be a gamecher as far as health 5:09 and longevity. So there is a quality control issue and there is a hidden 5:14 variable in peptide medicine with this and it’s one of the most underappreciated aspects of peptide 5:21 therapy particularly for non-FDA approved peptides. It’s quality control. 5:26 When we discuss pharmaceutical medicines, we take for granted that the pill contains what the label says. Not 5:32 always true depending on where it comes from. You guys, if you’ve heard my episodes before talk about how many of our medications are made in China and 5:41 have been contaminated with other things, you will realize that that is not always true. So, just because it has 5:48 the FDA stamp of approval on the medication, it still does not necessarily mean it’s safe and we still 5:54 need to do our homework on it. So, sorry for digressing on you guys, but you know, when we get a medication, we we 6:00 think that what the amount says is what is there, doesn’t have contaminants, it’s manufactured with good 6:06 manufacturing practices. You’ll see that listed as GMP on the bottle, and it’s been stored properly, it’s been 6:12 maintained stable, and with research peptides and compounded formulations, 6:17 none of this can be assumed. So, I will share a story with you. There was a gentleman that was purchasing these 6:24 peptides online from a research facility and um did not know that they were 6:30 coming from China and he was ordering a particular growth hormone peptide and 6:35 after a little while he had he had done fine for the few first few bottles. After a little while he started having 6:42 some complications. He started getting really irritable and angry and ragy and 6:47 he didn’t quite know what was going on. And so he decided to go get some testing done. He had some blood testing done and 6:53 his testosterone level was over 5,000. So for those of you who know what testosterone level should be for a guy, 7:00 they really shouldn’t be any higher than about 1,00200 would be absolute max that we’d want to see. Now he was taking 7:06 testosterone but not to that degree. And prior to adding this peptide, his 7:12 testosterone was very stable. What they ended up finding out was the peptide that he was getting, whoever was 7:18 manufacturing it added testosterone to the peptide. They felt like if if it had growth hormone, that was great, but if 7:25 it had growth hormone and tes testosterone, all the better. And he didn’t know that. And this is the 7:31 problem that we can have with peptides if you don’t source them properly. if you’re not working with somebody that 7:37 knows how to source them and can prove that they are what they say they are. Um, I’m sure there’s a whole bunch of 7:42 studies out there too of people getting these peptides and paying hundreds of thousands of dollars for them over their 7:48 lifetime and finding out they were nothing more than just sterile water. So, you really do need to be careful 7:53 with your quality control. Now, this kind of leads us right into the next topic that we’re going to talk about and that’s the manufacturing question, 8:00 right? The FDA approved peptides are manufactured in facilities subject to 8:05 the FDA inspection rules following our GMP regulations and these facilities 8:11 must validate their manufacturing process, demonstrate consistency batch to batch, test for purity and potency. 8:18 They need to test for bacterial endotoxins and sterility and they need to maintain detailed records. So, when a 8:25 pharmaceutical company submits a drug application, the FDA inspects the manufacturing facility as part of the 8:32 approval process. If you’re getting peptides from a different country, none of that is happening. And there are some 8:38 ways for us to determine if that is what you’re getting. Typically, the rule of thumb is if your peptides are coming 8:44 with a different colored top, every one of them has a different colored top. Those are typically being sourced out of 8:49 China. I wouldn’t say that’s 100% but that’s kind of the rule of thumb that people follow. So compoundingies these 8:56 are thearmacies that make our bio identical hormones. They can make medications in any dose or strength or 9:02 route. There are thousands of them in every not that not in every state but 9:08 there are thousands of them around the country right now. So these compoundingies are registered as 503A 9:15 facilities. They do traditional compounding for individual prescriptions, right? Like they can make 9:20 thyroid, they can make LDN, they can make estrogen. You can also have a 503b 9:27 facility, which is an outsourcing facility. And these companies produce larger batches of products. They’re they 9:34 have some oversight, but they’re less stringent than for FDA approved 9:40 manufacturers. And state boards of pharmacy regulate a 503A pharmacy. And 9:45 the FDA can inspect the 503b facility, but doesn’t preapprove any of their 9:52 compounding products. So, they can inspect it, but they don’t approve them. So, research chemicals and these 9:58 suppliers operate essentially with no oversight. They explicitly market products for research use only, not for 10:06 human consumption to avoid FDA regulation. If they put that on their 10:12 product, they don’t have to comply to what the FDA is saying. And there is no required manufacturing strategies or 10:19 standards, no required testing, no required sterility assurance, and no enforcement mechanisms if products are 10:26 mislabeled or contaminated. So basically, they don’t have the liability, but that doesn’t mean that 10:31 all of them are badies or bad suppliers. It just means they don’t have to comply 10:37 to the FDA rules. Now, there are many of these companies that I’ve seen and I’ve talked to that do do a lot of this. They 10:44 do test their product for sterility. They do test their product to make sure it is what it says it is. They don’t 10:51 have to, but they do. So, if you’re going to decide to use a company that 10:56 has research only, not for human consumption, at least ask for their 11:02 proof of testing so that you know that the product you’re getting is what it says it is and that it’s clean. Because 11:08 this is where we run into the problem is in purity. So in purity peptide 11:13 synthesis can produce not just the targeted peptide but also related 11:19 peptides with deletions, substitutions, truncations or truncations of amino 11:25 acids. Sorry. And this high performance liquid we call it uh chromatography can 11:30 separate these related impurities and quality and quantify the actual target 11:35 of the peptide content. So a certificate of analysis is what you want to ask these companies for. This shows the HPLC 11:44 the testing mechanism with greater than 95% or ideally 98% purity which 11:51 indicates a higher quality product. So this certificate of analysis can be fabricated may not represent the 11:57 specific batch being sold. It happens. We need to know not everybody is honest. Not everybody, you know, does what they 12:03 say and it does what’s right. But at least you at least they’re giving you something and you have some security. 12:10 and then choose a company that was referred to by someone else that has done some homework as well. In in 12:16 commercial research, there’s independent testing and they research peptides and this has been really shocking 12:23 variability that they’ve seen. Some products contain 50% or less of the 12:29 claimed peptide and some contained primarily degradation of the product or manufacturing impurities and some 12:36 contained bacterial endotoxins at levels that could cause fever and systemic 12:42 inflammation if it was truly injected. And I would also worry with some of those problems, you know, depending on 12:48 what impurity or bacterial endotoxin was there. If you’re using a product to boost your immune system and your immune 12:54 system is already compromised, these bacterial endotoxins can actually make you sicker instead of what you want it 13:02 to do, which is making you better. So, sterility is always an issue with anything that is manufactured, 13:08 especially things that we’re doing as an injection. Peptides are intended for injection. They must be sterile. They 13:16 must be kept safe. And pharmaceutical manufacturers conduct this sterility testing on every batch. 13:22 Compoundingarmacies should conduct sterility testing particularly for high-risisk compounded 13:28 sterile preparations and research chemical suppliers may or may not conduct any testing. So injecting 13:35 non-sterile material can cause local infections, abscesses at the injection 13:41 site and or if the bacteria enters the bloodstream could potentially be 13:46 life-threatening and you could have sepsis. Now, excuse me. We saw this 13:52 happen in a compounding pharmacy uh gosh, it’s probably been 10 years ago 13:57 now, I think. um they unfortunately had a strep uh contamination in their 14:03 product and they weren’t testing it. It was a large compounding pharmacy out of Florida and they were making products 14:08 that were being injected into the joints and um these people got very very sick 14:14 and some of them died and um some of them got very very injured by this uh 14:21 complication that happened. So it’s not like this doesn’t happen. It does, but it doesn’t happen often. And that’s what 14:28 we have to know about. And so, when we’re talking with you guys about storage and stability, it’s really 14:34 important to make sure you maintain your peptides well. So, many peptides are unstable at room temperature. They 14:41 require refrigeration or freezing. We tell everyone to make sure you’re refrigerating your peptides. That way, 14:48 there’s no question about it. when it stays cold um it prevents or slows down 14:54 the process of uh bacteria growing in it. So some of these peptides actually 14:59 degrade very rapidly in the solution and they must be reconstituted immediately before use and reconstitution of the 15:07 peptides really has limited stability often just days to weeks not months. So 15:13 improper storage, temperature, um changes during shipping or prolonged 15:19 storage of a reconstituted product can lead to degradation into inactivity or 15:25 potentially even a harmful breakdown of the product itself. So if you have a product that’s been sitting in your 15:30 refrigerator for a month or two months or 3 months or 6 months, just throw it away. It’s not going to be any good. 15:37 you’re not going to actually get the peptide and the uh potency that you’re looking for anyway out of it and the 15:44 potential of you introducing an endotoxin, a bacterial endotoxin is quite high at that point. So you just 15:50 really don’t want to take the risk, excuse me. So what practitioners, what 15:56 should we do and what should patients do? Well, for any peptide therapy, we 16:03 want to source our verification. know where the peptide product comes from. Is 16:08 it an FDA approved product? Is it a 503b compounding? A research chemical 16:14 supplier? Is there a certificate of analysis? Request and review this COA. 16:20 And you want it to show purity greater than 95% but ideally greater than 98%. 16:27 You want that identity be identity to be confirmed by mass spectromedy. Uh 16:33 sterility testing should be done. Bacterial endotoxin testing should be done. Batch number matching of the 16:39 product that you received should be done. Proper storage. You want to know that this has been refrigerated or 16:46 frozen as directed once it’s been mixed. Look at the expiration dates for reconstituting your peptides. Track that 16:53 reconstitution date and discarded accordingly like we just talked about. Monitor for your adverse effects. Even 17:01 with the perfect quality control, monitoring for adverse effects is essential with questionable quality and 17:08 vigilance is really critical here. I know it’s frustrating for a lot of patients when they have to get several 17:15 bottles and they only last a week or two. right here, you guys. This is why 17:21 they only last a short period of time because once they’re mixed, they start 17:26 to degrade and they won’t be good and you won’t get the benefit from it. So, 17:31 it’s really important with these research peptides specifically, practitioners should recognize that all 17:38 recommending products without quality assurance violates the fundamental medical principle of first do no harm. 17:45 If a patient is determined to use research peptides despite counseling, providing guidance on quality 17:52 verification, requesting those COAs, using pharmaceutical grade sources when available, proper testing, this all 17:59 reduces harm, but doesn’t constitute necessarily that recommendation. Now, 18:06 that being said, today it’s very difficult to find peptides by the compoundingies because of what the FDA 18:13 has done. So most of the peptides that are available to us have been labeled 18:18 not for human consumption, not because they’re not good products, but because 18:25 of what the FDA did. And this is how these companies have been able to 18:31 continue to provide peptides to the medical community. And if you know you 18:36 have a good company, then you’re, you know, you’re still taking the risk, right? But at the end of the day, the 18:42 reason they’re doing that is to protect themselves from the FDA, from liability. Um, so just kind of know that there is 18:50 some talk in the community with um Bobby Kennedy that this is going to change and 18:55 they are going to bring peptides back to the compounding pharmacies. Now, we don’t know which ones they’re going to 19:01 bring back. Uh, will it be all of them? Will it just be some of them? What’s going to happen here? Um, is it going to 19:07 go to the pharmaceutical companies like our GLP1s did? We don’t know what that’s going to look like quite yet. Um, but it 19:14 is coming and that is positive news. So, let’s talk now about FDA approved 19:21 peptide medications. So, this is the metabolic revolution, right? GLP1 19:28 and our dual increeting agonists. This is an exciting time. GLP-1s are amazing. 19:35 Um, a lot of people are skeptical, a lot of people love them, a lot of people hate them. Whichever side of the fence 19:42 that you’re on, I understand. But I want to talk about the science of it today 19:48 and what it actually means for people. So, the story of GLP1 glucagon like 19:54 peptide one represents one of the most significant advances in metabolic 19:59 medicine in the past several decades. GLP-1 is an accretin hormone. It’s 20:05 gutder derived peptide that potentiates insulin secretion in response to food 20:11 intake. And the body naturally produces GLP-1 in the intestinal L cells, but it 20:17 rapidly degraded by the enzyme DPP4 giving it a halflife of only about 2 20:24 minutes. So this rapid breakdown made in therapeutically impractical until 20:31 research was developed and modified the analoges that resist the enzyme degradation. So for those people who 20:39 never feel full when they’re eating, never feel satisfied when they’re done, this is because their body is either not 20:46 producing enough GLP1 or it’s not getting the signal right. And this is a 20:51 leptin issue. This is an insulin issue. It’s a GLP-1 issue. It’s a complicated 20:56 issue. This is not anything that the person is doing wrong. It’s what is happening to their body. And so GLP1s 21:03 have really revolutionized this. So one particular GLP-1 that we have is 21:09 semiglutide. And this GLP-1 agonist is what changed everything in the world of 21:16 metabolic medicine. Semiglutide is marketed as ompic for type 2 diabetes 21:23 and it’s marketed as WGOI for chronic weight management. It is a modified 21:29 GLP-1 analog with 95 or sorry 94% amino acid sequence uh homology to human 21:37 GLP-1. So it means that it’s it’s just like our own GLP-1 that we make. This 21:42 modification includes specific amino acid substitutions and the addition of C18 21:50 a fatty acid chain which allows the peptide to bind to albumin. Now this 21:56 albumin binding dramatically extends the half-life to approximately one week 22:01 enabling one weekly dosing which is a major advantage over the earlier GLP-1 22:07 agonists that require daily or twice daily injections. The mechanism by which 22:13 semiglutide works is multiaceted. At the pancreatin level, it binds to GLP-1 22:20 receptors on the pancreatic beta cells enhancing glucose depending sorry 22:27 enhancing glucose dependent insulin secretion. This glucose dependency is 22:33 crucial. It means the peptide only stimulates insulin release when blood glucose is elevated. This dramatically 22:41 reduces the hypoglycemic risk compared to insulin or even uh sulfuras. 22:47 Simultaneously semiglutide suppresses glucagon secretion from pancreatic alpha 22:53 cells further improving glycemic control. This is really amazing because 23:00 over the years when we’ve used insulin, which is also a peptide by the way, you 23:05 had to dose it just right because if you didn’t, you would produce so much insulin that it would crash the blood 23:12 sugar and then somebody would have too low of a blood sugar. They’d be hypoglycemic and they’d have to eat more 23:18 sugar and then they’d have to modify the insulin again and the person would be going up and down, up and down, up and 23:24 down all day long. And that created a lot of problems for people and so this 23:30 helps to stabilize that so it is not such an intense change. Now in the GI 23:36 tract semiglutide delays the gastric emptying particularly pronounced during 23:41 the initial weeks of therapy. This slowing of the gastric emptying contributes to the sensation of being 23:48 full and early satiety that patients often describe. However, this effect 23:54 tends to attend to weight over time as the body adapts through the appetite 24:00 suppressing effects generally persist through central mechanisms. So, when we 24:05 talk about what is actually happening, we’re slowing that digestive process down. That’s why people aren’t so 24:11 hungry. It’s why they’re not eating so much. This is why people can develop constipation with these products because 24:17 it’s slowing the body’s digestive tract down. Now some people will call this 24:22 gastroparesis. Um gastroparesis is actually different. 24:28 It is when we lose control over what’s happening in the in the colon like the 24:34 nerves and things like that just stop working. I have never seen that with the GLP1s that we prescribe in micro doing. 24:42 um it’s been documented. It can happen, but again it a lot of it is dosing and a 24:48 lot of it is staying on top of your client and what’s happening and what’s going on and what you’re doing and making sure that they do have good 24:54 motility still. So a lot of these things can be mitigated if you have problems 24:59 with them. Now one of the most profound effects of semiglutide occur in the 25:05 central nervous system. GLP-1 receptors are widely distributed in the brain 25:10 particularly in the hypothalamus and the brain stem area where we are involved in 25:15 appetite regulation. So when when wilding and colleagues published their 25:20 landmark step one trial in the New England Journal of Medicine in 2021, 25:25 they demonstrated that participants receiving 2.4 4 milligrams of semiglutide weekly achieved an average 25:32 weight loss of 14.9% of their body weight over 68 weeks. Now, I want you 25:39 guys to really understand this. We’re talking roughly 15% body weight loss 25:45 over a year, longer than a year. 52 weeks is a year, right? This is 68 25:50 weeks. So, it took longer for them to lose. We’re not talking about giving 25:55 somebody a dose to lose 15% of their body mass in a month or two. That that 26:01 is not healthy for any of us. That is not what we’re talking about doing here. Now, they compared this to placebo and 26:08 the placebo was only 2.4%. So, that is a significant difference. 26:14 And even beyond the numbers, patients reported something very qualitatively different, a reduction in what’s now 26:21 called food noise. Everybody knows what food noise is. We’ve talked about this long before GLP1. It’s that craving. 26:28 It’s that part of your brain that just keeps thinking about I want to eat something. You know, that was actually 26:34 reduced and they didn’t expect to see that happen. Now, this refers to the constant mental preoccupation with food, 26:42 the intrusive thoughts about eating, the difficulty in feeling satisfied. Semi-glutide appears to appears to 26:49 modulate reward pathways in the misolyic system reducing hedonic eating and food 26:57 cravings. Now there are also great cardiovascular effects of semiglutide 27:02 that extend beyond weight loss. Uh the sustained six and select trials 27:07 demonstrated significant reductions in major adverse cardiovascular events uh 27:14 mace in high-risisk populations. The select trial published in 2023 showed 27:20 that semiglutide reduced cardiovascular death, non-fatal myioardial inffection 27:25 and non-fatal stroke by 20% in adults with overweight or obesity and 27:31 established cardiovascular disease but without diabetes. So this suggests that 27:37 mechanisms beyond glucose control and weight loss possibly including 27:42 anti-inflammatory effects, improvements in endothelial function and favorable 27:47 changes to lipid profiles. Now I will tell you the clients that I work with that are on GLP1, 27:53 they will tell you that their inflammation has been significantly reduced. We are also seeing really 28:00 amazing results in lipid profiles. um part of its weight loss, but there is a 28:06 component to this that is lowering the triglyceride levels because it’s related to sugar and how the body’s processing 28:11 it. And we’re seeing better profiles, less need for statins as a result of 28:17 that. If if you want to listen to my episode on statins, I have one on that. Uh they are not my favorite medication. 28:24 I think it’s overprescribed and overused um and not really affecting or 28:29 addressing the problem. So these things can really be helpful. There’s also some 28:34 uh ramblings going on with GLP-1s saying that they may be able to help with 28:40 addiction in the future because of where they’re finding it affecting the brain and how it affects the food noise and 28:47 the cravings that we have for food and the addiction for food. Could it potentially help with other addictions 28:53 down the road? We’ll have to wait and see on that one. So semiglutide’s FDA prescribing information also includes a 29:00 box uh boxed warning about thyroid sea cell tumors. So in rodent studies 29:06 semiglutide caused dose dependent and treatment duration dependent sea cell 29:12 tumors at clinically relevant exposures. So while it’s unknown whether or not 29:17 semiglutide causes uh thyroid cancer tumors in humans and the rodent thyroid biology 29:26 differs significantly from humans, the drug is contraindicated in patients with a personal or family history of 29:33 medillary thyroid carcinoma or in patients with multiple endocrine neopl neoplasia syndrome type two. it is 29:42 uh contraindicated for safety effects with that. Um I have seen endocrinologists okay GLP1s to be used 29:50 in patients who’ve had other forms of thyroid cancer just not the meillary 29:55 thyroid cancer. So there is possibility there. Now the most common side effects 30:00 are gastrointestinal. It’s nausea affects about 20 to 44% of patients 30:06 depending on the formulation with diarrhea, vomiting, constipation, abdominal pain, and also frequently 30:13 reported in clinical trials. I see this in my clinic, too, especially dose dependent. Um, and it happens early on 30:20 when you’re first starting the medication, but seems to settle out over time. The one that I would add to this 30:26 that I don’t think they have on here is an increase in acid reflux. We also see that quite often uh especially in people 30:33 who suffer with acid reflux to begin with. Now these effects are typically most 30:40 pronounced during the escalation and they like I said often improve over time 30:45 but more serious but less common adverse effects include acute pancreatitis. 30:51 The medication needs to be discontinued immediately if this is confirmed. You can see some diabetic retinopathy 30:57 complications in patients with pre-existing retinopathy and acute kidney injury. Um, this usually happens 31:05 secondarily to dehydration from the GI effects. There are some gallbladder disease um that can occur and people who 31:13 have a sensitive gallbladder will describe uh discomfort with that. I’ve 31:18 even seen some people who’ve had their gallbladder out on GLP1s at the higher doses complain of similar pain that they 31:25 used to have when their gallbladder was in. So, really important to just kind of monitor these symptoms and work closely 31:32 with somebody that understands them and can be on top of them quite quickly if this happens. Excuse me. From an 31:39 integrative medicine perspective, semiglutide really represents a powerful tool, but it’s not a standalone 31:46 solution. Remember, the medication addresses one aspect of the metabolic dysfunction, the signaling systems 31:53 controlling appetite and glucose homeostasis, but it doesn’t address the root cause that led to the metabolic 32:00 disease in the first place. Patients who rely solely on the medication without addressing the ultrarocessed food 32:07 consumption, the ccadian disruptions, the chronic stress, the sleep apnea, or 32:12 underlying hormonal imbalances often experience weight regain when the medication is discontinued. 32:20 The drug is also not a substitute for addressing the emotional and psychological drivers of eating 32:26 behavior, including the unresolved trauma that may manifest as emotional eating. I think this is really important 32:33 because we don’t address the trauma issue enough with clients and we need to 32:38 be looking at that. There is a huge trauma effect out there these days that is I don’t want to say leading to or 32:45 causing but it is definitely contributing to chronic illness and it’s not being talked about enough. So we 32:52 really need to be talking about this and addressing this trauma aspect. Now the next GLP that one that I want to talk 32:59 about is trespathide. This is a dual agonist. It takes center stage. It is my 33:05 favorite GLP one. Trisepatide is marketed as Mangjaro for type 2 diabetes 33:11 and Zepbound for chronic weight management and it represents the next 33:16 evolution in increantbased therapy. This is a dual agonist a 39 amino acid 33:23 synthetic peptide structurally based on the human glucose dependent insulin tropic peptide so GIP sequence but 33:31 modified to activate both the GIP receptors and the GLP1 receptors. So the 33:37 addition of the GI GIP agonism to the GLP1 agonism appears to create this 33:46 synergistic effect that goes beyond simply adding the two mechanisms together. So the GIP like GLP-1 is an 33:55 increant hormone secreted by what is called the K cells in response to nutrient intake. It enhances glucose 34:02 dependent insulin secretion but it also effects on atapost tissue metabolism 34:09 potentially improving the insulin sensitivity in fat cells and influencing 34:14 how the body stores and metabolizes fat. So some research suggests that GIP may 34:20 also have effects on energy expenditure though this remains an area of 34:26 investigation. So basically what we’re saying is this drug may actually help 34:32 people who are insulin resistant or insulin sensitive, not just somebody who 34:38 has problems with glucose control. So, this is super exciting because it opens 34:43 up the door for all of these people for decades that we’ve been trying to manage with insulin resistance and trying to 34:50 prevent diabetes and honestly most of the time have been unsuccessful 34:56 unless you can keep your diet at 50 grams of carbs or less a day, which is extremely difficult. Um, and take some 35:04 supplements that may or may not work and or take some metformin that may or may not help. this drug actually really 35:11opens that up and helps in that capacity. So there was a clinical trial 35:17 called the surmount clinical trial which demonstrated that trespathide produces 35:22 even more substantial weight loss than semiglutide. In the surerount one trial published by uh J tree I might have said 35:31 that wrong. I apologize if I slaughtered your name and colleagues in the New York England Journal of Medicine in 2022. 35:38 Participants receiving the highest dose of trespide, which is 15 milligrams, achieved an average weight loss of 20.9% 35:47 of their body weight over 72 weeks, compared to 3.1% with placebo. This 35:54 level of weight loss approaches what’s typically only seen in beriatric surgery. So, this is amazing because if 36:02 this medication works and we don’t have to do beriatric surgery, stomach stapling basically, um, oh my gosh, it’s 36:11 amazing. There are so many complications and risks that go with stomach stapling and the different procedures that they 36:17 do these days. People don’t absorb their nutrients properly. They have to do liquid nutrients. It’s very complicated. 36:24 It’s very challenging. Many of these people gain their weight back. Um, and 36:30 this procedure is not fun to go through. So, if we could change that and change 36:35 the lives of people who’ve really been struggling, it is amazing. And I will tell you that I have seen this work. I 36:42 have seen people lose 100 150 pounds on these medications over a year or two 36:50 period of time. It is definitely slower than beriatric surgery on some standpoints, but that is okay. You don’t 36:56 want that rapid weight loss. It’s not good for you. It’s not healthy for you. It doesn’t look well. You know, we want 37:03 to do this safely and effectively in the best way that we can possibly do that for you. Now, the adverse effect profile 37:10 is similar to semiglutide. It’s dominated by gastrointestinal effects. 37:15 Nausea, diarrhea, decreased appetite, vomiting, constipation. These were all commonly reported in the surmount 37:22 trials. And like semiglutide, tricepide carries a blackbox warning regarding the 37:27 thyroid sea cell tumors based on the rodent data and it shares the same contra indications in patients with a 37:34 family history of thyroid cancer and men too. So the mechanism behind why 37:40 tepatide often produces more substantial weight loss than GLP-1. The agonism 37:45 alone remains under investigation, but it may relate to the complimentary effects on the different aspects of 37:51 energy homeostasis or to GIP’s effects on atapost tissue and potentially on 37:58 central central nervous system pathways that GLP1 alone doesn’t fully address. 38:03 Now patients often report even more profound reductions in food noise with tricepide compared to GLP1 and uh sorry 38:12 GLP1 the agonists through this is anecdotal and hasn’t been regularly 38:17 quantified in quality studies. So I’ve done both uh personally and in my 38:22 practice. I really like trespide better than semiglutide. For me I had too many side effects with semiglutide. uh I had 38:30 less side effects with trespathide. I also plateaued on semiglutide which I 38:35 didn’t really care for. And with Tresepide, I haven’t plateaued and I’ve been able 38:42 to lose about 25 pounds in um a year and a half and I’ve been able to maintain 38:49 that. Um and I continued to use it because I do have a strong family history of cardiovascular disease. And 38:56 if this could help me so that I don’t follow my family lineage with cardiovascular disease, I am all for 39:03 trying to do that. I’ve watched too many of my family members suffer from this. I’ve lost my dad at a very young age. I 39:09 lost my grandfather at a young age to it. All of their brothers to this. And I don’t want to be that same person. So 39:16 that is why I chose to do that. And I think it’s really important for us to take a look at that and understand that. 39:24 Now, I know this has been a really long podcast and I don’t typically do podcasts this long. I have a whole host 39:31 of information on additional peptides. So, I’m going to break this up for you 39:36 guys and I’m going to do another episode and we’re going to pick up where we left off here with these peptides so that we 39:43 can actually start to dive into different peptides as well. So, check 39:48 out my next podcast show when we’re going to dive into the peptides that 39:54 talk about sexual wellness, immune function, and all the other cool things 39:59 that we can do with peptides. So until then, remember to like, share, and 40:04 subscribe. It really helps us get out to other people and share our information, 40:10 and join us for our next episode as we continue the talk about peptides. 40:15 Welcome to Let’s Talk Wellness Now, where we bring expert insights directly to you. Please note that the views and 40:21 information shared by our guests are their own and do not necessarily reflect those of Let’s Talk Wellness Now, its 40:28 management, or our partners. Each affiliate, sponsor, and partner is an 40:34 independent entity with its own perspectives. Today’s content is provided forformational and educational 40:40 purposes only and should not be considered specific advice, whether financial, medical, or legal. While we 40:48 strive to present accurate and useful information, we cannot guarantee its completeness or relevance to your unique 40:56 circumstances. We encourage you to consult with a qualified professional to address your 41:01 individual needs. Your use of information from this broadcast is entirely at your own risk. By continuing 41:08 to listen, you agree to indemnify and hold Let’s Talk Wellness Now and its 41:14 associates harmless from any claims or damages arising from the use of this 41:20 content. We may update this disclaimer at any time and changes will take effect 41:26 immediately upon posting or broadcast. Thank you for tuning in. We hope you 41:31 find this episode both insightful and thought-provoking. Listener discretion 41:36 is advised.The post Episode 256 – How Peptides Work, Benefits, and FDA-Approved vs Off-Label Use Explained first appeared on Let's Talk Wellness Now.

In this episode of Data in Biotech, Ross Katz sits down with Kyle Smith and Jacob Mayer from Aprecia Pharmaceuticals to explore how 3D printing is transforming pharmaceutical manufacturing. They dive into the unique binder jetting process, in-cavity printing, and how real-time data and automation are enabling agile, scalable, and precise drug production. Discover how Aprecia's approach is changing the game for clinical trials and personalized medicine. What you'll learn in this episode: >> How Aprecia developed the world's first FDA-approved 3D printed drug >> Why binder jetting stands out among 3D printing methods in pharma >> How in-cavity 3D printing enables real-time tablet-level data collection >> The future of closed-loop control and digital twins in drug manufacturing >> Why 3D printing is key to agile, distributed, and personalized pharma production Meet our guests: Kyle Smith is President and COO of Aprecia Pharmaceuticals, leading strategic growth and innovation in GMP-regulated pharma manufacturing. With 12+ years at Aprecia, he brings deep expertise in engineering, operations, and technology transfer. Jacob Mayer is Director of Engineering Innovation at Aprecia Pharmaceuticals. With a decade of experience across automation, additive manufacturing, and life sciences, he leads the advancement of 3D printing technologies and integrated pharma systems. About the host Ross Katz is Principal and Data Science Lead at CorrDyn. Ross specializes in building intelligent data systems that empower biotech and healthcare organizations to extract insights and drive innovation. Connect with our guests: Sponsor: CorrDyn, a data consultancyConnect with Jacob Mayer on LinkedIn Connect with Kyle Smith on LinkedIn Connect with us: Follow the podcast for more insightful discussions on the latest in biotech and data science.Subscribe and leave a review if you enjoyed this episode!Connect with Ross Katz on LinkedIn Sponsored by… This episode is brought to you by CorrDyn, the leader in data-driven solutions for biotech and healthcare. Discover how CorrDyn is helping organizations turn data into breakthroughs at CorrDyn.

In this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance under the NMPA.The conversation explores why Western companies often underestimate China's regulatory expectations — particularly when assuming EU or U.S. approvals, ISO standards, or FDA clearances will translate directly. Elaine explains how China requires demonstration of safety and effectiveness against applicable local standards primarily GB (national standards) and YY (medical device industry standards) including both mandatory and recommended variants (e.g., GB vs GB/T, YY vs YY/T).The episode dives into China's local type testing model and the role of Product Technical Requirements (PTRs) in defining test methods, parameters, accessories, and applicable standards for registration.Elaine also outlines how China's quality system expectations align to China Medical Device GMP rather than ISO 13485 including major GMP updates taking effect in November 2026 and discusses implications for foreign manufacturers.Additional discussion topics include China agents and authorized representatives, clinical evaluation expectations, post-market reporting requirements, and how China's device classification system can influence regulatory strategy.⏱️ Timestamps00:00 Welcome + Meet Elaine (MedTech Chopsticks)00:38 Why China Is Different: Local Standards vs EU/US Assumptions03:35 GB & YY Standards Explained (National vs Industry Standards)05:07 Local Type Testing & PTRs: Building China Product Technical Requirements06:52 China GMP Updates: Key Differences vs ISO 1348512:42 China Agent vs EU Authorized Rep: Roles & Responsibilities15:19 Choosing Local Test Labs: NMPA-Designated Testing Considerations18:42 Planning Early: Standards Gaps, Clinical Evaluation & PMS Risks24:43 China Certification & Device Classification Changes (Class I/II/III)28:38 Where to Find Elaine + ClosingSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Dealing with an FDA Complete Response Letter (CRL) is one of the most stressful challenges in drug development, but managing one that stems from a failed inspection at your Contract Development and Manufacturing Organization (CDMO) adds a unique layer of business and operational complexity.In this episode of Life Science Solutions, host Chris Adkins sits down with David Dlugo (Senior Director of Quality at Kymanox) and Anthony Stewart (Senior Process Engineer at Kymanox) to dissect a real-world case study of remediation and return to GMP manufacturing following a failed Pre-Approval Inspection (PAI).The team explores how to navigate the delicate balance between a Sponsor's need for oversight and a CDMO's need to protect proprietary operations, often using a "middleman" strategy to diffuse tension and accelerate compliance.Topics Include:The "Survival Mode" Dynamic: Understanding the friction between a Sponsor's urgency and a CDMO's competing resource demands.Common Technical Pitfalls: Why "basic GMPs" and process control strategies (like Annex 1/contamination control) are frequent stumbling blocks during first-time inspections.The Power of Generalists: Why deploying a team of deep, diverse experts is more effective than just "throwing bodies" at a remediation project.6 Keys to Success: David shares six essential steps to prevent CRLs, including robust supplier qualification and monthly governance meetings.Ideal Knowledge Transfer: How to leave the CDMO better than you found it by mentoring staff and improving quality systems for the long haul.Whether you are navigating a current regulatory hurdle or preparing for your first BLA, this conversation offers a strategic roadmap for turning regulatory complexity into clarity.

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In this episode, our host Philippe welcomes Paul Michel, Senior Consultant at SkillPad, with over 27 years of experience in the pharmaceutical and biopharmaceutical industries, including more than two decades in manufacturing. Paul specializes in GMP training, compliance readiness, and supporting organizations through the complexities of product development and commercial manufacturing. Together, they explore the realities of GxP compliance in biopharma manufacturing — from the scientific complexity of biologics and evolving regulatory expectations to the growing demand for specialized quality skills and the expanding role of CDMOs. The conversation highlights how automation, digital maturity, and strong quality foundations are becoming essential to sustain growth in this fast-evolving sector.   Key Takeaways 02:11 Why biologics manufacturing is fundamentally more complex than small molecule production 04:10 How living cell systems introduce variability and demand tight process control 05:29 Why scale-up in biomanufacturing is scientifically challenging and risk-prone 10:00 The role of ICH Q5 guidelines and comparability studies in biologics compliance 13:06 The growing demand for advanced quality skills in biologics and digital environments 17:18 How modern CDMOs enable faster development from DNA to IND through platform approaches 20:47 Why automation and digitalization are critical to closing the CDMO capacity gap   Contact Paul Michel on LinkedIn here: Paul Michel (He/Him) | LinkedIn Contact us at solabs-podcast@solabs.com for questions or feedback!

He's back on the GMP! No doubt with a few opinions on life in Portugal in recent times...Become a supporter of this podcast: https://www.spreaker.com/podcast/the-good-morning-portugal-podcast-with-carl-munson--2903992/support."The one you're thinking of is Good Morning Portugal! hosted by Carl Munson. It's an English-language live show/podcast aimed at expats (especially 50+ folks) settling into or loving life in Portugal. It's streamed live on YouTube weekdays around 8-9 AM (often with a cheerful Olá Bom Dia ALEGRIA! vibe), covering news, weather, culture, wellbeing, property tips, moving advice, and fun chats. Carl helps people buy, rent, or scout homes—contact him at +351 913 590 303 or carl@carlmunson.com if you need that. You can catch full episodes on YouTube (channel: Good Morning Portugal!), as a podcast on Spotify/Apple, and join the free Portugal Club community at theportugalclub.com for more support and connection. It's super positive, community-focused, and still going strong in 2026!" - Grok

Send a textMike Romance has spent nearly two decades operating at the intersection of manufacturing engineering, automation, validation, and operations leadership within the life-sciences ecosystem. His career spans startups and established organizations alike, with hands-on experience taking products from early development through GMP-ready, high-volume production. Across roles in process development, automation, quality systems, and manufacturing strategy, Mike has built a reputation for combining technical rigor with pragmatic execution.Most recently at Quantum-Si, Mike played a central role in scaling operations to support the commercialization of the Platinum protein sequencing platform while laying the groundwork for next-generation technologies like the Proteus platform. Working within a lean and highly agile leadership team, he helped establish scalable manufacturing foundations spanning CM-managed instrument supply, internal reagent kit production, and advanced silicon-based consumables—while navigating the realities of fast-moving product roadmaps and constrained resources.Earlier in his career, Mike held engineering and leadership roles at organizations including Illumina, Dexcom, GenMark Diagnostics, Truvian, and Encodia. Along the way, he's led pilot-line development, automation strategy, equipment qualification, validation programs, and process controls—often in environments where the path forward wasn't clearly defined.What sets Mike apart is not just his command of acronyms—GAMP, CQV, QbD, DFSS, FMEA—but his philosophy that systems only work when people do. He actively practices emotionally intelligent leadership, prioritizing trust, clarity, and psychological safety while still holding teams to high technical and operational standards. As Mike explores his next chapter, this conversation focuses on the lessons he's learned building resilient manufacturing systems—and the kind of organizations where he believes he can make the biggest impact next.LINKS:Guest LinkedIn: https://www.linkedin.com/in/mikeromance/Aaron Moncur, host The Wave is  a place for engineers to actively learn, share ideas, and engage with people doing similar work. Learn more at thewave.engineer Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us Watch the show on YouTube: www.youtube.com/@TeamPipelineus

When your biosimilar analytical data shows 1.4% high mannose against a 6% reference product specification, you face limited options: process temperature shifts that compromise titer, kifunensine supplementation that requires extensive regulatory justification, or 12-18 months to reclone and revalidate. Media supplementation offers an alternative pathway—tuning glycan profiles through formulation adjustments rather than cell line or process re-engineering.In this episode, David Brühlmann presents the experimental development of a media supplementation strategy that achieved 2.8-fold increases in high mannose glycans across multiple CHO cell lines. Drawing from research published in the Journal of Biotechnology (2017, 252:32-42), the discussion covers the mechanism of raffinose-mediated glycan processing arrest, the experimental variables that initially obscured the effect, and the process development considerations for implementing media-based glycan tuning.The episode examines N-glycan biosynthesis in CHO cells, regulatory comparability requirements for biosimilar glycosylation profiles, and the experimental framework for evaluating media supplementation as a glycan control strategy.Highlights from the episode:The unexpected link between dietary raffinose and reduced athletic performance, and its connection to bioprocessing (01:11)A clear primer on the importance of glycosylation for biosimilar drugs and regulatory approval (02:43)Common challenges when glycan profiles don't match reference products, and why high mannose glycans matter (04:19)A review of industry strategies (temperature shifts, enzyme inhibitors, cell line reengineering) and their pitfalls (05:33)Mechanistic insights into how raffinose alters glycan processing in CHO cells (07:05)Key experimental findings on raffinose concentration, osmolality control, and practical lab troubleshooting (09:48)Application stories and regulatory considerations for implementing raffinose-based media adjustments (13:47)Closing thoughts on process optimization, regulatory impact, and what to expect in Part 2 (15:11)Strategic insight:Implementing raffinose as a media supplement is straightforward, regulatory-friendly, and cost-effective. It does not involve genetic engineering or enzyme inhibitors and is easily sourced as a GMP-grade material. For programs approaching submission with glycan comparability gaps, media-based tuning offers a process optimization pathway that maintains existing cell lines and manufacturing platforms while addressing critical quality attribute specifications.Listen to this episode of the Smart Biotech Scientist Podcast to learn David's best strategies for rapid, regulatory-friendly glycosylation control.If you want to transform your glycoengineering workflow, keep an eye (and ear) out for the next episode of the Smart Biotech Scientist Podcast. Your path to regulatory success might be as simple as a pinch of raffinose.Resources: Journal of Biotechnology, 2017, volume 252, pages 32 to 42Next step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

Can Morocco's famous hash industry survive pharmaceutical regulation?In Part 2 of Episode 166, Trevor and Kirk continue their conversation with Jan van Weenen, a European cannabis veteran helping transform Morocco's ancient hash market into a GMP-compliant pharmaceutical industry. From heavy metals in Rif Mountain soil to pricing battles between farmers, co-ops, and manufacturers, this episode reveals the real-world challenges of global cannabis regulation.Jan shares his strategy to build a pharmaceutical cannabis brand now — and pivot into recreational markets later — while navigating European standards, extract distribution, and international licensing.Listen now to explore the birth of Morocco's legal cannabis industry and what it means for Europe and beyond.Jan van Ween - LinkedInTranscripts, papers and so much more at: reefermed.ca

When I talk about warehouse sanitation, I often say, “It's a great way to get your foot in the door.” And every now and then, someone pushes back and says, “I don't want to clean restrooms or take out trash.” I understand that reaction. On the surface, sanitation doesn't sound exciting. It doesn't come with a forklift, a title, or a clipboard. It came up again this week so I wanted to explain a little better what the warehouse sanitation role really is, what it teaches you, and why it has launched more warehouse careers than people realize. Because warehouse sanitation is not just cleaning. It's operations support. It's safety. It's compliance. And for the right person, it's a proving ground. Think of it like this. At its core, warehouse sanitation exists to protect people, product, and the process. A clean warehouse is a safer warehouse, a compliant warehouse, and ultimately a more productive warehouse. Yes, sanitation associates may clean restrooms and remove trash, although a lot of times that's more of a role for the janitorial folks and departments, anyway, that work matters more than people realize. But in a warehouse or production environment, sanitation includes maintaining dock areas, storage aisles, production zones, and shared spaces so that operations can run without interruption and bottlenecks. Sanitation associates are often the first ones to notice leaks, spills, or damaged flooring, broken pallets and debris buildup, blocked exits or fire equipment, and unsafe conditions developing in the aisles, cross aisles, and dock areas over time. In many operations, especially your larger distribution operations, sanitation is not a background function, it is a frontline safety and compliance role. Auditors, inspectors, and customers notice cleanliness immediately, and sanitation teams are often the unsung reason a facility passes inspections. One of the most valuable things a sanitation associate learns is Good Manufacturing Practices, or GMPs. GMPs teach the why behind the rules. Why food can't touch the floor. Why personal items are restricted in production areas. Why cleaning tools and equipment are color-coded and why documentation is so important and matters. Sanitation associates learn how contamination happens through people, equipment, and behavior. They learn how one mistake in one area can affect product quality downstream. Once someone understands GMPs, they become valuable across the entire warehouse. Receiving, picking, packing, shipping, and quality all rely on the same principles. GMP knowledge changes how people move, touch, store, and think about product. Sanitation associates don't just follow rules, they help enforce a culture of cleanliness and accountability. And sanitation work is structured. There are daily, weekly, monthly, and quarterly cleaning schedules that must be followed. Sometimes called the Master Sanitation List. This teaches sanitation associates how to manage time independently, how to prioritize critical areas, and how to complete work without constant supervision, and then most importantly, how to properly document completed tasks. Schedules don't care if someone is motivated or not, the work still has to be done. Associates who learn to stay on schedule develop discipline quickly. When managers look for leads or trainers, they often look for people who can manage their time without reminders. Sanitation associates who consistently complete schedules are already proving they can handle responsibility. We also may be given classes, training, and certifications on handling cleaning chemicals, another area where sanitation roles quietly build professional skills. Associates are trained on proper dilution ratios, PPE requirements, SDS sheets, and safe storage practices. They learn that stronger is not better, and that improper mixing can create hazards instead of preventing them. Chemical misuse can damage floors and equipment, create slip hazards, most importantly violating safety regulations. Learning to follow chemical procedures teaches precision, patience, and respect for process. Again, traits that are essential in equipment operation, quality roles, and leadership. Those next steps we're all after. Ok, what else did I make notes on. Alright, this is where the sanitation role starts to surprise people. Warehouse sanitation often involves powered and equipment and machines, and that equipment brings even more responsibility into play. Think of Industrial floor sweepers, walk-behind or ride-on, remove debris that creates safety hazards. Sanitation associates trained on sweepers learn to perform pre-use inspections, monitor battery levels, and operate safely around pedestrians and forklifts. They learn right-of-way rules, speed control, and awareness of blind spots. Now, we need to remember that sweepers operate in active aisles. That means sanitation associates must anticipate traffic patterns, understand dock activity, and adjust their cleaning routes based on production flow. This isn't random driving, it's operational awareness and has to be treated as such. And the floor scrubbers require even more thought. These machines deep clean concrete floors and are essential in GMP environments. Associates learn how water flow, detergent concentration, and recovery systems work together. They quickly learn that too much water or chemical creates slip hazards and damages floors. Scrubbers require planning, which areas are active? Which areas can be blocked for a while? How to communicate wet floors? That kind of forward thinking kind of mirrors the decision making required of supervisors and leads. Oh, and trash compactors. Trash compactors are powerful machines with strict safety rules. Sanitation associates learn load limits, prohibited materials, cycle timing, and lockout awareness. Compactors teach one key lesson, procedures exist for a reason. There are no shortcuts, no “just this once.” They can be dangerous. This mindset, follow the process every time, is exactly what safety managers look for when selecting people for advancement. And Balers. Many facilities recycle their cardboard, shrink wrap, and slip sheets. We'll learn how to sort materials properly, safely load the baler, tie off the bales, and document counts or weights. Many facilities track recycling metrics, which introduce sanitation associates to cost control and sustainability efforts. Balers build organization skills and attention to detail, two traits essential in inventory control and leadership roles. What else did I note here, Sanitation associates work everywhere. They see inbound, outbound, production, and all of the common areas. They notice how shifts hand off work, where bottlenecks form, and where safety issues seem to repeat themselves. That exposure creates, what I like to call, big-picture thinkers. People who understand how departments interact often become strong supervisors because they already understand the operation as a whole. Remember how I'm always mentioning to understand the task before and after ours? So where can all this take us? Sanitation experience often leads to general warehouse associate roles, Forklift and equipment operator positions, quality control or safety support roles, inventory control or clerical positions, facilities or building maintenance support, and yes, front line management. Some of the most effective leaders I deal with started in sanitation, and they respect every role and understand compliance better than most. So about that, I don't want to clean mindset. Here's the truth I share often, careers aren't built by avoiding necessary work. Sanitation teaches discipline, humility, consistency, and accountability. Remember, managers notice who shows up, with a positive attitude, follows procedures, and does the work, even work that others avoid. Sanitation isn't about trash. It's about trust. Warehouse sanitation doesn't have to be a forever job, but it can be a powerful starting point. And it can be a great career. It builds safety awareness, equipment experience, operational understanding, and work ethic. Sanitation isn't a dead end. It's a foundation. And as we've learned, strong foundations support long careers. Well, I have to get back to work now myself. I hope I shed some light on why I feel sanitation is one of the strong starting points in our industry. I'd appreciate it if you'd pass the episode along to a friend, ask them to subscribe on Apple Podcast, Spotify, or any of their favorite Podcatchers, we're even on YouTube! Let's all do our part to bring more of those entering the workforce into our Industry. Until next week, please give every action and movement the respect it deserves, our family and friends need us to be safe and come back home as well and in as good of health as we left!

When cannabis products began failing state microbial tests, @Radsource turned to an unexpected solution: medical x-ray technology. In this episode, George Terry and David Hyde explain how photonic, through-transmission decontamination eliminates pathogens like salmonella, E. coli, and aspergillus without harming cannabinoids or terpenes. This conversation, hosted by MJ Gibson live at MJBizCon 2025 breaks down why contamination is an agricultural reality, how regulations are evolving, and what proven, GMP-backed technology means for cannabis safety and product quality.WEBSITE: https://cannatechtoday.com/Make sure to follow our other social media platforms to stay up-to-date on all things Cannabis & Tech Today.https://twitter.com/cannatechtodayhttps://www.facebook.com/CannaTechTodayhttps://www.instagram.com/cannatechtoday

In this episode, we sit down with Kendall McWilliams, '20 Chemical Engineering, M.P.S. Biotechnology Student, to talk about what it really takes to build a meaningful career in biotech.Kendall shares his journey from chemical engineering into the biotech industry, and why pursuing graduate education was the logical next step. He explains how understanding quality systems, GMP regulations, clinical trials, and business operations transformed how he approaches his work—especially in bringing promising therapies from research to patients.The conversation also dives into how AI and data modeling are being used responsibly in bioprocessing, why human judgment still matters, and how constant learning is simply part of the profession. Kendall offers honest insight into balancing full-time work with graduate school, navigating different roles within biotech, and staying grounded in the industry's ultimate purpose: protecting and improving lives.This episode is especially valuable for working professionals considering graduate study, career-changers exploring biotech, or anyone curious about how science, regulation, and ethics come together in real-world biotech work.Learn more about UMBC's M.P.S. in Biotechnology: https://professionalprograms.umbc.edu/biotechnology/

Ever feel like your supplement cabinet is full but your energy is still empty? We take you behind the label to show exactly why some products change lives and others change nothing. With Emily from Orthomolecular, we unpack the real markers of quality—verified sourcing, GMP manufacturing, third-party testing, and forms your cells can actually use—so you stop guessing and start feeling a difference.We start with the fish oil you love to hate. If your softgels smell rancid, cause burps, or require a handful to hit a therapeutic dose, you're not imagining it. Source, processing, and form separate effective EPA/DHA from junk. Then we tackle magnesium: oxide and citrate may keep you regular, but chelated bisglycinate supports sleep, mood, heart rhythm, and muscle calm because it gets inside cells. We also talk about the digestion piece too many overlook—low stomach acid from stress or long-term PPIs can block absorption, turning even good formulas into expensive decorations.From there, we map the essentials most women need: vitamin D3 with K2 to protect bones and arteries, omega-3s to dial down inflammation, and an advanced multivitamin with activated B vitamins for energy, methylation, and hormone metabolism. On gut health, we share why a multi-strain, shelf-stable probiotic can be a smart daily “maintenance” choice, and how Saccharomyces boulardii acts like a cleanup crew for the GI tract, helping maintain barrier integrity and support immunity.If you're ready to simplify, we explain how to audit your cabinet, check forms and doses, toss expired or ineffective products, and consolidate into a lean, therapeutic stack that works. No hype—just practical steps, clear explanations, and products designed to meet label claims and clinical standards. Subscribe, share with a friend who's supplement-confused, and leave a review telling us the one change you're making this week.Shop supplements: Shop.fasttofaith.com use code PODCAST for a discount! If you're ready to move beyond trying harder and start living more aligned, you're invited to join Empowered by Faith — LIVE, a guided 5-day reset led by Dr. Tabatha that helps women reset body, mind, and spirit through simple, faith-centered rhythms.

Kim Bright is a pioneering figure in the nutrition industry, recognized as an expert in health and wellness. She has been active since the 1980s, appearing on nationally syndicated and local radio and television programs to educate audiences on optimizing their health. Over her career, she has personally consulted with more than 15,000 individuals and delivered lectures to groups across the United States. Bright studied under well-known health experts and industry leaders, and she both attended and taught at The Kushi Institute in Massachusetts. She established a health center in Connecticut, where she offered consultations and taught courses on healthy lifestyles alongside international health experts. In 1985, Bright opened A Change of Season’s Restaurant in Westport, Connecticut, which was the state’s first non-smoking restaurant. As its chef and owner, she emphasized locally sourced, seasonal organic ingredients, with a menu featuring fresh fish, organic chicken, daily-made soups, salads, juices, breads, cookies (including gluten-free options), desserts, macrobiotic dishes, and vegetarian and vegan selections—no processed foods, red meat, or alcohol were served. In 1996, Bright founded Brightcore Nutrition, a family-owned nutraceutical company now in its 27th year as of recent profiles Brightcore’s products are manufactured in the USA in FDA-inspected, GMP-certified facilities, with ingredients rigorously researched and third-party tested for potency, quality, and safety. By selling directly to consumers, the company maintains premium quality at accessible prices. Bright’s work with Brightcore has included discussions on topics like the benefits of fermented foods and wheatgrass juice powder for energy and skin health in various interviews and podcasts 

Jaunty's rise to the top of the New York cannabis market was not an overnight success.It was built through discipline in a market uniquely designedNew York's rollout remains unforgiving.One store openings, supply and demand constraints, and continuous price compression forced every decision into the open.This week we sit down with Nicolas Guarino, Co-Founder and CEO of Jaunty, to break down what it actually takes to survive and scale in one of the most interesting cannabis markets in the country.This week we sit down with Nick to discuss:Why consistency becomes the only real moat as prices fallHow New York's rollout punished assumptions and rewarded preparednessCapital discipline, supplier trust, and avoiding overspend death spiralsChapters00:00 Introduction to Jaunty and Nicolas Guarino03:06 The Journey into the Cannabis Industry06:07 Challenges and Lessons Learned in CBD09:00 Transitioning to Recreational Cannabis11:54 Building a Brand in a Competitive Market15:07 Navigating Market Dynamics and Growth Challenges18:07 The Importance of Support and Resilience20:49 Understanding Market Economics and Consumer Behavior23:55 Future Prospects for Cannabis in New York31:48 The Economics of Cannabis Production36:29 The Importance of Consistency in Branding41:11 Navigating Challenges in Cannabis Operations46:10 Strategic Planning for Future Growth51:56 Inventory Management and Cost Control56:02 Preparing for Market Consolidation58:11 Final Thoughts and Future Directions About: Nicolas Guarino is Co-Founder and CEO of Jaunty. As a GMP-certified 100% New York company working in cannabis extraction since 2017, Jaunty has been producing and distributing the finest solventless hash, live resin, and distillate cannabis products in its mission to close the gap between flower and oil. With state-of-the-art manufacturing facilities in Hoosick Falls, NY, Jaunty is one of New York's leading companies licensed for all adult-use cannabis supply chain activities outside of retail, including cultivation, processing, manufacturing, and distribution. They produce and distribute one of New York's best-selling cannabis vape brands, available in all of the state's licensed dispensaries, and their product portfolio also features gummies, concentrates, and disposable vapes.SummaryIn this episode, Bryan Fields interviews Nicolas Guarino, co-founder and CEO of Jaunty, discussing his journey in the cannabis industry, the challenges faced in the CBD market, and the transition to recreational cannabis. They explore the importance of brand consistency, financial strategies for growth, and the dynamics of the New York cannabis market. Nicholas shares insights on consumer education, market predictions, and the future vision for Jaunty emphasizing the need for adaptability and resilience in a fast-paced industry.Guest Linkshttps://jaunty.com/https://x.com/getjauntyhttps://www.linkedin.com/company/get-jauntyhttps://www.instagram.com/get_jaunty/https://www.linkedin.com/in/nicolas-guarino-43939b103/Our Links:Bryan Fields on TwitterKellan Finney on TwitterThe Dime on TwitterExtraction Teams: Want to cut costs and get more out of every run? Unlock hidden revenue by extracting more from the same input—with Newton Insights.At Eighth Revolution (8th Rev), we provide services from capital to cannabinoid and everything in between in the cannabinoid industry.The Dime is a top 5% most shared  global podcastThe Dime is a top 10 Cannabis Podcast The Dime has a New Website. Shhhh its not finished.

Janet Ryan, founder of SpectraSpray Global, discusses what her product does, how she started her company, which countries she sells to, the difference between FDA and GMP approval, and offers sage advice to women entrepreneurs.

Patricio var vittnet som gav upphov till fantombilden som har fått namnet "Skuggan".GRK säger på s253-54: Från PU:s sida har uppgivits att Patricio M:s uppgifter är falska ochatt anledningen till att han kontaktade polisen var att han villeneutralisera den bild som givits i medierna om att gärningsmannenkunde vara utländsk. Han hade därför lämnat ett signalement somstämde på en man med nordiskt utseende. Den bedömningen har ocksåredovisats i GMP (se under nästa rubrik). Vi har inte kunnat klarläggagrunden för denna bedömning; den kan inte utläsas ur det registreradeutredningsmaterialet.Hur kom det sig att Patricios vittnesmål avskrevs på oklara grunder?Programledare. Dan HörningResearch: Gunnar WallSponsra Palmemordet på Patreon: https://www.patreon.com/palmemordetKontakta Palmemordet: zimwaypodcast@gmail.com Hosted on Acast. See acast.com/privacy for more information.

For over 4,000 years, silkworms have connected civilizations through ancient trade routes. Now, KAICO Ltd., a Japanese biotech spin-off from Kyushu University, is transforming these creatures into living bioreactors capable of producing complex recombinant proteins and vaccine antigens—without the bioreactors, expensive media, or massive water consumption of conventional platforms.Masafumi Osawa, Business Development Lead at KAICO, brings an unconventional path to biotech. Trained in cultural anthropology with fieldwork experience in Indonesia, he witnessed firsthand the healthcare disparities that drive his current mission. After years in pharmaceutical business development at Towa Pharmaceutical, he joined KAICO to help scale a technology he believes could reshape global vaccine accessibility. His cross-cultural expertise now proves invaluable as KAICO expands internationally, with active partnerships in Vietnam and Thailand and growing interest from other regions.Episode highlights:Masafumi's transition from anthropology to biotech, and how cross-cultural expertise benefits global health collaborations. (04:15)The founding story of KAICO, spun out from Kyushu University and focused on recombinant proteins and vaccine antigen production (08:45)Step-by-step overview of the silkworm baculovirus expression system, including pupae handling and bioprocessing basics. (10:28)Practical differences between silkworms, E. coli, mammalian, and insect cell culture platforms—exploring advantages and drawbacks. (13:10)Strategies KAICO uses to control silkworm variability, including SPF grade sourcing, diet, environment, and documentation for pharmaceutical acceptance. (15:08)Production scalability: a single pupa can match 100–1000 ml of insect cell culture, with major implications for cost and environmental footprint. (16:42)Downstream harvesting and purification—how KAICO extracts and processes proteins from silkworm pupae, keeping methods largely familiar to traditional systems. (19:31)Regulatory and GMP challenges of using live organisms, and KAICO's approach to satisfying authorities and ensuring product consistency. (21:43)Whether you're curious about alternative biomanufacturing methods or want a transparent look at silkworm-based protein expression from research to the clinic, this episode delivers practical insights and thoughtful discussion.Connect with Masafumi Osawa:LinkedIn: www.linkedin.com/in/masa-osawaKAICO Ltd.: www.kaicoltd.jp/enNext step:Need fast CMC guidance? → Get rapid CMC decision support hereOne bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.Support the show

What if the most powerful “sugars” aren't fuel at all, but messages your immune system has been waiting to hear? We sit down with Dr John Lewis, a former professor whose lab uncovered striking cognitive improvements in people with moderate to severe Alzheimer's after 12 months on a formula built from aloe and rice bran polysaccharides. The science takes us beyond calories and cravings into complex carbohydrates as signaling molecules—shaping inflammation, immune balance, and possibly neuroplasticity.We unpack polysaccharides 101, separating starch from functional giants like aloe acemannan and rice bran compounds. You'll hear how these dense, 3D structures can influence CD4/CD8 ratios, natural killer cell activity, TNF-alpha, VEGF, and even CD14 cells tied to neural repair. The clinical story is matched by lived moments from caregivers who witnessed language and daily function return. We also dig into why conventional funding passed on this line of research, the dominance of amyloid-focused paradigms, and the gap between public talk about nutrition and what actually gets resourced.If you've wondered whether food could deliver these effects, we cover the practical realities: aloe gel is mostly water, rice bran is milled off white rice, and even daily brown rice may not supply meaningful doses—especially for older adults managing chronic inflammation. That's where concentrated, third-party tested, GMP-produced supplementation can fit: small grams-per-day inputs that favor immune modulation without stimulants or sugar spikes. Along the way we explore prevention, aging, and how steady immune signaling may guard brain health long before problems start.Subscribe for more deep, evidence-led conversations on brain health, nutrition science, and longevity. If this episode challenged your view of “sugar,” share it with a friend and leave a review to help others find the show.https://drlewisnutrition.com/ Use "Lufkin10" for 10% off.Lies I Taught In Medical School : Free sample chapter- https://www.robertlufkinmd.com/lies/Complete Metabolic Heart Scan (LUFKIN20 for 20% off) https://www.innerscopic.com/Fasting Mimicking Diet (20% off) https://prolonlife.com/Lufkin At home blood testing (20% off) https://siphoxhealth.com/lufkin Web: https://robertlufkinmd.com/X: https://x.com/robertlufkinmdYoutube: https://www.youtube.com/robertLufkinmdSubstack: https://robertlufkinmd.substack.com Instagram: https://www.instagram.com/robertlufkinmd/LinkedIn: https://www.linkedin.com/in/robertlufkinmd/TikTok: https://www.tiktok.com/@robertlufkinThreads: https://www.threads.net/@robertlufkinmdFacebook: ...

A Canadian Good Manufacturing Practices ("GMP") compliant, pharmaceutical drug manufacturer licensed by Health Canada for the handling of controlled substances and GMP production. From two 10,000-square-foot facilities in British Columbia and operating under a Drug Establishment License from Health Canada, Optimi supplies active pharmaceutical ingredients and finished dosage forms to regulated channels, with products currently in market for prescription use in Australia via the Authorized Prescriber Scheme and accessible in Canada through the Special Access Program.

Episode Description You trust that expensive fish oil is molecularly distilled and free from mercury. You believe your magnesium is actually absorbed. You assume your creatine is pure pharmaceutical-grade powder. But can these brands prove it—or are you swallowing contaminated, oxidized, low-potency supplements that do more harm than good? Dr. Christian Gonzalez investigated the supplement industry with one critical question: can the most popular longevity supplements prove they're free from heavy metals, microplastics, and oxidation through third-party testing and Certificates of Analysis (COAs)? The shocking reality? Most can't—or won't—provide basic proof of purity. You're expected to trust your mitochondria, brain health, and long-term performance to manufacturers who refuse transparency about what's actually in the bottle. The hidden dangers lurking in "premium" supplements: • Fish oils contaminated with mercury, lead, microplastics, and oxidized rancid fats that trigger inflammation instead of reducing it • Magnesium oxide marketed as "magnesium" with 4% absorption—meaning you're literally flushing your money down the toilet • Creatine cut with heavy metals, banned substances, and fillers that negate performance benefits and contaminate your system • Vitamin D formulated in seed oils and synthetic carriers that interfere with absorption and create inflammatory byproducts • Fiber supplements loaded with inulin blends and maltodextrin that spike blood sugar and cause severe digestive distress • Zero verification of potency claims—dosages listed on labels that have no relationship to what third-party testing reveals inside • Supplements stored in conditions that degrade active ingredients months before expiration dates In this episode, Dr. Christian Gonzalez reveals: • The 5 most studied supplements for longevity, brain power, and energy—and exactly how to buy the cleanest versions • Why Omega-3 fish oils are either your greatest longevity tool or a toxic inflammatory bomb depending on purity testing • The one form of magnesium that actually works (and the three forms that are complete scams stealing your money) • How creatine monohydrate boosts ATP in your muscles AND brain—but only if it passes strict third-party certification • Why Vitamin D without K2 can calcify your arteries while you think you're "optimizing" your health • The soluble fiber that lowers all-cause mortality by 11%—and why most fiber supplements use the wrong type • Exact evidence-based doses, timing strategies, and quality markers so you never waste money on fairy dust formulas again • The certifications that actually matter: IFOS, NSF, Informed Sport, Creapure, and why "GMP certified" means nothing • How to read COAs and spot red flags in oxidation scores, heavy metal panels, and microplastic screening This episode goes beyond basic supplementation—it's about understanding that your cellular membranes, mitochondrial function, and long-term disease prevention depend on purity, not marketing. It's about demanding proof before putting daily supplements into your body, and recognizing that the supplement industry profits from your trust, not your health outcomes. The supplement industry doesn't want you asking for COAs. But your brain, heart, and longevity depend on it. My one stop shop for quality supplements: https://theswellscore.com/pages/drg Timestamps: 0:00 - Introduction 1:07 - #1: Omega-3s for Brain & Longevity  4:41 - How Much Omega-3 Do You Actually Need?  7:42 - #2: Magnesium for Energy & Nervous System  12:42 - #3: Creatine for Muscle & Brain Energy  16:07 - #4: Vitamin D3 + K2 for Immune & Bone Health  20:22 - #5: Soluble Fiber for Gut Health & Longevity

你生活中使用的彩粧品、防曬、護膚乳液，真的安全嗎？ 很多民眾不知道，牙膏、漱口水其實也屬於化粧品！這些產品若製程不當，可能藏有污染與品質不穩定的風險。 本集邀請食藥署謝綺雯簡任技正，深入解析化粧品GMP (優良製造準則)，從原料到包裝全程把關，讓熟齡族天天用得安心，這是你生活中不可錯過的健康美麗必修課！ ✅ 本集節目重點 1.為什麼牙膏、漱口水、護唇膏都算「化粧品」？ 2.化粧品GMP是什麼？從製程到上市的品質保證機制。 3.認明登錄、看懂標示，選對產品保護自己和家人。 4.食藥署如何輔導廠商，確保產品品質與國際接軌。 主持人：《50+》特約主持 簡劭瑜 來賓：食品藥物管理署醫療器材及化粧品組 簡任技正 謝綺雯 製作團隊：50+整合傳播部 免費訂閱食藥署藥物食品安全週報：https://www.fda.gov.tw/TC/Epaper_Subscribe.aspx (食品藥物管理署廣告）

Starmer calls The Doctor strikes “Utterly irresponsible” Plus: Former Labour elected Mayor Jamie Driscoll joins the Greens, yet ANOTHER bad day for Keir Starmer, and GMP vow to clamp down even more on Pro-Palestine protesters. With: Michael Walker, Ash Sarkar, Dr Thomas Cheliotis-James & Jamie Driscoll

In this episode of Data in Biotech, host Ross Katz sits down with John Liberty, Senior Bioanalysis Technical Sales Consultant at Thermo Fisher Scientific. They dive deep into how Watson LIMS™ supports regulated bioanalysis workflows, the evolving role of lab automation, and how Connect Enterprise aims to unify biotech digital ecosystems. What you'll learn in this episode: >> Why Watson LIMS is purpose-built for bioanalysis and how it enhances compliance and data traceability. >> The role of lab automation in boosting productivity and reducing manual tasks. >> How Connect Enterprise integrates lab systems across vendors into a seamless workflow.  >> Key considerations for implementing LIMS in startup versus established biotech environments. >> The ROI of digital lab solutions in supporting scalable, compliant biotech operations. Meet Our Guests John Liberty is a GMP-trained scientist with a strong focus on ELISA method development, validation, and transfer. He pairs his hands-on scientific background with experience in project management, CRO coordination, data analysis, and training, making him someone who really understands how work moves from the lab bench to real-world application. John has also spent time on the product and customer side, doing technical sales and demos for Watson LIMS™ software, giving him a rare blend of technical depth and communication skills. About The Host Ross Katz is Principal and Data Science Lead at CorrDyn. Ross specializes in building intelligent data systems that empower biotech and healthcare organizations to extract insights and drive innovation. Connect with Our Guest: Sponsor: CorrDyn, a data consultancyConnect with John Liberty  on LinkedIn  Connect with Us: Follow the podcast for more insightful discussions on the latest in biotech and data science.Subscribe and leave a review if you enjoyed this episode!Connect with Ross Katz on LinkedIn Sponsored by… This episode is brought to you by CorrDyn, the leader in data-driven solutions for biotech and healthcare. Discover how CorrDyn is helping organizations turn data into breakthroughs at CorrDyn.

Today, we're thrilled to talk to husband-and-wife dream team, Laurie & John Masiello. The Masiellos have been launching and scaling life science companies together since 1984. After merging their first company, Masy BioServices, with a North Carolina CDMO in 2021, the Masiellos struck again, forming Predictive Monitor in 2022. Their debut product, OverShield, combines IoT sensor technology with AI and data analysis to offer a powerful early warning system for controlled GMP chambers, from freezers to cold and stability rooms. The couple's mission centers around harnessing Pharma 4.0 technology to maximize equipment uptime, improve operational efficiency, and protect life-saving biopharmaceutical products.Hear Laurie & John walk us through their incredible shared journey and industry insights as they prepare to celebrate their 50th wedding anniversary.https://www.linkedin.com/company/predictive-monitor-llc/ Qualio website:https://www.qualio.com/ Previous episodes:https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show:https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Setting up a cannabis processing facility means navigating GMP standards, cleanroom requirements, and equipment choices. Learn from experts who've designed compliant operations across multiple markets and avoid the costly mistakes that derail new ventures. To learn more, visit: https://hempirelabs.com Hempire Labs S.L. City: Sotogrande Address: C.C., Mar y Sol Local 3.9 Website: https://hempirelabs.com

This week on America on the Road, co-hosts Jack Nerad and Chris Teague get behind the wheels of two fascinating 2025 and 2026 model-year vehicles that approach electrification from very different angles. Jack tests the refreshed 2025 Hyundai Ioniq 5 Limited AWD, an EV that combines futuristic design, high-speed charging, and luxury-grade comfort. Meanwhile, Chris reviews the all-new 2026 Subaru Crosstrek Sport Hybrid, which brings a new hybrid powertrain and off-road chops to a beloved crossover. And in our special guest segment, Jack sits down with Polestar 4 Product Manager Ola Aldensjö to discuss the Swedish automaker's sleek new battery-electric SUV and its first-of-its-kind lane-level AI navigation system.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Leonel Venegas, a seasoned quality and regulatory professional who has worked with global leaders including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.Leonel shares how integrating Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP) is essential to successful combination-product development. He discusses his journey from chemist to regulatory-affairs expert, uncovering common disconnects between pharma and device cultures, and the critical role of design controls, risk management, and timelines.The conversation also explores GMP and process validation, IDE vs. IND pathways, the challenges of rare-disease programs, and how understanding the cost of quality can reshape testing strategies. Leonel closes by reflecting on becoming a Lean Six Sigma Black Belt and what continuous improvement really looks like in combination-product development.⏱ Timestamps00:00 – Welcome & Introduction00:52 – Integrating GLP, GCP & GMP02:22 – Challenges in Developing Combination Products04:02 – Device-Led Combination Products07:35 – Working with Rare Diseases09:58 – GMP & Process Validation15:08 – Clinical Trials: Drug vs Device19:22 – Cost of Quality & Six Sigma25:12 – Conclusion & Contact InformationLeonel Venegas is the Founder of Precision Regulatory Consulting LLC and an expert in quality and regulatory affairs with over two decades of experience across six global pharma and medtech leaders, including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.He is certified by ASQ as a CMQ/OE, CQE, CBA, and CSSBB, and holds an M.S. in Regulatory Affairs. Leonel specializes in combination products, medical devices, and IVDs, integrating GLP, GCP, GMP, and GVP principles into complex global development programs.

Send those pics & vids to the GMP! studio on 00 351 913 590 303Become a supporter of this podcast: https://www.spreaker.com/podcast/the-good-morning-portugal-podcast-with-carl-munson--2903992/support.Let us help you find YOUR home in Portugal...Whether you are looking to BUY, RENT or SCOUT, reach out to Carl Munson and connect with the biggest and best network of professionals that have come together through Good Morning Portugal! over the last five years that have seen Portugal's meteoric rise in popularity.Simply contact Carl by phone/WhatsApp on (00 351) 913 590 303, email carl@carlmunson.com or enter your details at www.goodmorningportugal.com And join The Portugal Club FREE here - www.theportugalclub.com

Remii “Rock Steady” is a third-generation chemist, cannabis process engineer, and pharmaceutical cannabinoid developer in the cannabis and hemp industry.Expect to learn about the endocannabinoid science (how THCA becomes Δ9 THC, why CBGA is the “alpha,” and what β-caryophyllene really does), pharma-grade production (GMP cleanrooms, dronabinol/API validation, and why documentation rules everything), and the industry's crossroads (THCA-hemp loopholes, rescheduling vs. descheduling, and safe vs. risky conversions like HHC/THCP).Do you support descheduling cannabis to protect craft operators?Follow Remy “Rock Steady”:Instagram: @_rock_steady._YouTube: Rock Steadyy's WorldWebsite:  @rocksteadysworld 

Become a supporter of this podcast: https://www.spreaker.com/podcast/the-good-morning-portugal-podcast-with-carl-munson--2903992/support.Let us help you find YOUR home in Portugal...Whether you are looking to BUY, RENT or SCOUT, reach out to Carl Munson and connect with the biggest and best network of professionals that have come together through Good Morning Portugal! over the last five years that have seen Portugal's meteoric rise in popularity.Simply contact Carl by phone/WhatsApp on (00 351) 913 590 303, email carl@carlmunson.com or enter your details at www.goodmorningportugal.com And join The Portugal Club FREE here - www.theportugalclub.com

Dr. Jeff Graham talks with Dr. Mattias Bernow, a physician, economist, and CEO of Cellcolabs — about the current state of stem cell therapy. They discuss how mesenchymal stem cells (MSCs) function through signaling rather than cell replacement, where evidence supports their use today, and why good manufacturing practices (GMP) are essential for safety and efficacy. The conversation explores clinical data on cardiovascular, autoimmune, and neurodegenerative diseases, and what large-scale, evidence-based production could mean for the future of regenerative medicine.

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Gil Roth, President, at Pharma & Biopharma Outsourcing Association (PBOA). Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Gil, covering: How planned FDA budget cuts and the ongoing US government shutdown are impacting the industry. And the potential outlook if those issues remain unresolved... Why positive early-phase clinical trial activity could signal a stronger year ahead Real-life applications of AI and machine learning for GMP in CDMOs through signal and pattern recognition Why Gil is feeling more optimism across the CDMO community And yes… you can also see Gil and Raman together on stage at the industry's very own “Super Bowl” of conferences Gil Roth is the Founder and President of the Pharma & Biopharma Outsourcing Association (PBOA), a nonprofit trade group that advocates for the regulatory, legislative and general business interests of the CMO/CDMO sector. In this role, he brings CDMO perspectives and education to FDA, the US Congress, and other bodies, and brings CDMOs together to share best practices, develop policy positions, and provide briefings on government positions that impact that sector. He also organizes and hosts PBOA's annual members-only Meeting & Conference. Previously, he was the Founding Editor of Contract Pharma magazine. In his alleged free time, he produces a weekly cultural conversation podcast called The Virtual Memories Show (https://chimeraobscura.com/vm).   Molecule to Market is also sponsored by Bora Pharma (boracdmo.com) and Charles River (www.criver.com), and supported by Lead Candidate. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating!

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Recent developments in these industries underscore a period of significant scientific progress, regulatory maneuvers, and strategic investments.One notable event was AstraZeneca and Daiichi Sankyo's success at the European Society for Medical Oncology Congress 2025. Their antibody-drug conjugate, Datroway, demonstrated superior efficacy compared to Gilead's Trodelvy in the first global head-to-head trial involving Trop2-targeted therapies. This reflects the increasing focus on antibody-drug conjugates as precision medicine tools that offer targeted treatment options with potentially improved outcomes over traditional chemotherapy.In a move highlighting the ongoing trend of bolstering domestic production capacities, Merck is making a substantial $3 billion investment in a small molecule drug plant in Virginia. This is part of a broader $70 billion commitment to expand manufacturing and R&D capabilities in the U.S. Such strategic investments are crucial for maintaining competitive advantage and ensuring drug availability while meeting rising demands and streamlining supply chains.Turning to regulatory updates, the FDA has approved Amgen and AstraZeneca's Tezspire for chronic rhinosinusitis with nasal polyps. This marks Tezspire's second indication, following its initial approval for severe asthma in 2021. The expanded approval showcases the drug's versatility and represents a strategic push to enhance its market presence against competitors like Dupixent.In oncology, Merck's Keytruda and Astellas/Pfizer's Padcev have made headlines with compelling results in muscle-invasive bladder cancer. The combination therapy reduced the risk of death by 50%, reinforcing Keytruda's position as a cornerstone immunotherapy across multiple cancer types. This result not only augments treatment options but also signifies the potential for combination regimens to enhance patient outcomes.Roche has expanded the indication of its aging oncology drug Gazyva to treat lupus nephritis, demonstrating strategic repurposing efforts to extend the lifecycle of existing therapies. While this expansion into autoimmune diseases comes late in Gazyva's lifecycle, it highlights a growing trend of capitalizing on established drugs for new therapeutic areas.AstraZeneca and Daiichi Sankyo's Enhertu showed robust efficacy in early breast cancer treatment, potentially reshaping therapeutic strategies by offering new hope for early intervention. Similarly, Novartis' Pluvicto demonstrated promise in slowing hormone-sensitive prostate cancer progression, underscoring the potential of radioligand therapies in oncology.However, not all developments have been positive. AstraZeneca faced setbacks when its Imfinzi and Lynparza combination failed to meet survival goals in ovarian cancer, underscoring the challenges inherent in oncology drug development and the stringent benchmarks set by regulatory authorities like the FDA.The industry is also witnessing significant advancements in next-generation ADCs, as evidenced by Tubulis' 59% response rate in early clinical trials, which has attracted substantial investor interest. Additionally, Grail's Galleri cancer blood test is progressing towards FDA review with enhanced performance data, potentially revolutionizing cancer screening and early detection practices.These scientific and regulatory milestones are complemented by strategic investments in bioconjugation technologies. Cohance Life Sciences' $10 million investment in NJ Bio to enhance GMP bioconjugation capabilities exemplifies this trend. Such investments are crucial for advancing ADC development, which remains a focal point for innovative cancer therapies.Overall, these developments reflect a dynamic phase for the pharmaceutical and biotech sectors characterized by signSupport the show

Send us a textIn this episode of the Life Science Success Podcast my guest is Troy Fugate. The CCO of Compliance Insight, Inc., Troy brings 30+ years of FDA readiness, GMP, and quality leadership—turning complex requirements into practical, culture-shaping solutions and championing the Align–Apply–Adapt framework used across pharma, cell and gene therapy, and medical devices.00:00 Introduction to Life Science Success Podcast00:37 Meet Troy Fugate: CCO of Compliance Insight01:09 Troy's Career Journey and FDA Focus04:10 The Align, Apply, Adapt Framework04:47 Differentiating Compliance Insight08:03 The Importance of Clarity in Compliance17:10 Challenges and Solutions in Compliance25:38 Human Behavior and Continuous Improvement34:39 Troy's Inspirations and Concerns39:07 Final Thoughts and Closing Remarks

The Cookware That's Secretly Poisoning Your Food Not all cookware is created equal. After months of investigating 21 major cookware brands, Dr. Christian Gonzalez uncovered a truth the industry doesn't want you to know: only one passed his strict standards for safety, transparency, and purity. Most companies, including billion-dollar icons like Le Creuset, Caraway, All-Clad, HexClad, and GreenPan - either ignored requests for safety data, relied on toxic PFAs coatings, or hid behind influencer marketing. In this episode, Dr. G exposes which brands are quietly contaminating your food, the dangerous materials to avoid, and how to choose cookware that protects your brain, hormones, and nervous system. To get the full updated product list, visit:

As AI becomes more integrated into pharmaceutical manufacturing, the question is not just how fast we can adopt it, but how safely. In this episode, Ben Locwin and Subhi Saadeh discuss the intersection of AI, GMP, and Quality 4.0, exploring both the promise and the challenges of applying intelligent systems in regulated environments.Key topics covered:- Current applications of AI in GMP, including CAPA and deviation management- The role of validation and why algorithmic opacity poses regulatory challenges- How Process Analytical Technology (PAT) enables real-time release decisions- The importance of Design of Experiments (DOE) for process optimizationContinuous manufacturing and how yield can signal process performanceChapters00:00 Introduction to AI in Pharma00:40 Current Applications of AI in GMP02:32 Challenges and Validation in AI03:22 Process Analytical Technology (PAT)09:50 Design of Experiments (DOE) in Pharma13:27 Continuous Manufacturing Explained15:40 Yield Calculation in Manufacturing22:12 Conclusion and Contact InformationBen Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

What if the key to unlocking ADC manufacturing success lies in abandoning the platform mindset entirely?Antibody-drug conjugates represent biotech's most promising weapon against cancer: precision-targeted therapeutics that deliver cytotoxic payloads directly to tumor cells while sparing healthy tissue. But beneath the clinical promise lies a manufacturing reality that's rewriting the rules of bioprocess development, demanding analytical strategies that most CDMOs simply aren't equipped to handle.In this deep-dive episode, David Brühlmann sits down with Amanda Hoertz, Vice President of Analytical and Formulation Sciences at KBI Biopharma, where she oversees 300+ scientists across the mammalian network. Amanda's team has cracked the code on some of the industry's most challenging ADC programs, achieving a remarkable 93% batch success rate by rejecting cookie-cutter approaches in favor of molecule-specific development strategies.What you'll discover:The Platform Fallacy: Why treating ADCs like standard monoclonals is costing companies millions and months of development time, and the bespoke analytical framework that's changing everything.Cytotoxic Payload Management: From free drug analysis to employee safety protocols, Amanda reveals the hidden complexities of handling molecules designed to kill cells, including the specialized facilities and analytical methods required for GMP manufacturing.Charge Heterogeneity Mastery: The analytical method that "keeps Amanda up at night," and the development strategies her team uses to achieve robust separation and qualification across multiple sites and analysts.This episode delivers the technical depth and strategic insights that bioprocess engineers need to navigate ADC development successfully. Whether you're evaluating CDMO partnerships, optimizing analytical methods, or scaling complex conjugates, Amanda's proven strategies will transform your approach to these game-changing therapeutics.Ready to master the analytical complexities that make or break ADC programs?Connect with Amanda Hoertz:LinkedIn: www.linkedin.com/in/amanda-hoertz-3aba605KBI Biopharma: www.kbibiopharma.comKBI Portal: www.standalone.kbi.bioNext step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call

This episode takes a deep dive into how collective behavior modification can transform organizational culture and reduce human error. We explore the science of group dynamics, reinforcement, and peer influence, then connect those principles to real-world GMP and high-reliability environments. From leadership modeling to process design and cultural reinforcement, we unpack strategies that make safe, reliable behavior the norm—not the exception.To learn more, visit:https://humanerrorsolutions.com/Listen to more episodes on Mission Matters:https://missionmatters.com/author/ginette-collazo/

Viral vectors are the backbone of cutting-edge cell and gene therapies, delivering life-altering treatments to patients with genetic diseases. But making these biological delivery vehicles is a high-wire act: unpredictable, complex, and fraught with hurdles that traditional biologics manufacturers have never faced.While the world races toward next-generation therapies, the challenge of producing viral vectors at clinical and commercial scale threatens to leave patients waiting on the sidelines.Our guest on the Smart Biotech Scientist Podcast is Lucas Chan, a molecular and cell biologist with over two decades of hands-on experience in cell and gene therapy development. From his formative research at Imperial College London, where he pioneered novel viral vector cell lines, to building the UK's first GMP clinical viral vector core and later founding CellVec Pte Ltd Asia Pacific CDMO in Singapore, Lucas is the go-to architect for manufacturing viral vectors where infrastructure barely exists.Along the way, he's faced and overcome challenges few others could imagine.Here are three reasons this episode is a must-listen:Viral Vectors Demystified: Lucas breaks down a common misconception: viral vectors aren't malignant viruses, but genetically disarmed delivery vehicles that can't revert or replicate, making them safe tools for gene therapy.Manufacturing Mayhem Made Manageable: Unlike monoclonal antibodies and other biologics, viral vectors (and other cell and gene therapies) are made in living cells, leading to a level of process unpredictability and complexity where “everything, everywhere, all at once” applies. Success hinges on scientific acumen and attention to even the smallest detail, from raw materials to equipment parameters, to ensure patient safety and product quality.Pioneering in Uncharted Territory: Moving from London to Singapore, Lucas faced not just technical but regulatory and logistical challenges to founding Asia-Pacific's first CDMO dedicated to viral vectors. His advice: engage regulators early, leverage local biomanufacturing strengths, and build multidisciplinary teams to transfer and scale bioprocess know-how.Curious how viral vector manufacturing can be reimagined to unlock the full promise of cell and gene therapies? Listen to this episode and gain unique insights into the science, strategy, and sheer determination needed to bring advanced therapies out of the lab and into the clinic.Connect with Lucas Chan:LinkedIn: www.linkedin.com/in/lucaschangtNext step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callPreparing for your IND? We're building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105

Join us on Skin Anarchy as Dr. Ekta Yadav sits down with Theresa Plavoukos, founder of Fat Mermaid, for a deep dive into beauty that begins from within. With over 25 years of experience spanning L'Oréal, Estée Lauder, and luxury fragrance development, Theresa shares how her extensive background in product innovation inspired her to create a collagen supplement that's as fun as it is effective.Discover the science behind liquid marine collagen—the most bioavailable form for hair, skin, and nail health. Theresa explains how its low molecular weight allows for quick absorption and superior efficacy compared to traditional powders or bovine formulas. The result: visible improvements in skin glow and hair strength without the guesswork or mess.The brand's playful name, Fat Mermaid, reflects its philosophy: lush, vibrant beauty fueled by nutrient-rich support. Behind the whimsical branding is serious science, with every batch produced in FDA-inspected, GMP-certified facilities and third-party tested for purity and amino acid transparency.Designed for real life, Fat Mermaid's collagen is unflavored, versatile, and easy to use. Whether you add it to coffee, smoothies, or take it as a one-ounce shot, its built-in dosing cup ensures the perfect clinically recommended amount every time.This episode is your insider look at how Theresa merges rigorous clinical standards with approachable, joyful design—proving that inner beauty can be both efficacious and delightful. Tune in to hear how Fat Mermaid is making bioavailable beauty effortless and inspiring.To learn more about Fat Mermaid, visit their website and social media.CHAPTERS:0:02 – Introduction & Guest Welcome0:59 – Theresa's Beauty Industry Background4:01 – Origins of Fat Mermaid & Personal Inspiration6:50 – Naming the Brand & Marine Collagen Choice10:00 – Bioavailability of Liquid Marine Collagen13:26 – Collagen Types & Type I for Hair, Skin, Nails17:07 – Unflavored Product & Supplement Stacking24:04 – Scientific Validation, Testing & Transparency29:03 – Sustainability & Marine Collagen SourcePlease fill out this survey to give us feedback on the show!Don't forget to subscribe to Skin Anarchy on Apple Podcasts, Spotify, or your preferred platform.Reach out to us through email with any questions.Sign up for our newsletter!Shop all our episodes and products mentioned through our ShopMy Shelf! Hosted on Acast. See acast.com/privacy for more information.

Send us a textIn this episode of the Grow Clinton Podcast, Andy and Jenny are joined by Justin Wilinson, Factory Manager at Nestlé Purina PetCare Company's plant in Clinton, Iowa.Justin is an experienced Director of Manufacturing with a proven success record in the food production industry. He is skilled in Safety Program Development, team building, leadership development, GMP, Six Sigma, Root Cause Analysis, Manufacturing, and Lean Manufacturing.Purina's Clinton factory produces some of the company's most popular pet food and treat brands and serves as a hub for innovative new products. The pet food production expansion includes new cooking and packaging lines that will support the manufacture of various pet food brands, including Purina ONE, Purina Pro Plan, and Purina Pro Plan Veterinary Diets. This expansion responds to growing demand from pet owners for nutritious, science-based dog and cat foods made with high-quality, trusted ingredients.The ongoing investments and expansions in Clinton position Nestlé Purina PetCare for continued growth and help meet the increasing demand from pet owners who trust Purina to deliver nutritious, high-quality dog and cat foods.For more information regarding the available career opportunities at the Clinton factory, please visit https://lnkd.in/gjQPaywB. To promote your business, organization, or event on the podcast, contact Grow Clinton at 563.242.5702 or www.GrowClinton.com.Grow Clinton values your feedback! Please complete a brief survey at https://lnkd.in/gfzKpUEM.Grow Clinton champions economic growth, fosters community, and supports the sustainable success of businesses in the Greater Clinton Region.Thank you for your ongoing support. ~Andy

Jane Weitzel has been working in analytical chemistry for over 40 years for pharmaceutical and mining companies.  She was elected to the United States Pharmacopeia Council of Experts as chair of the 2020-2025 General Chapters–Measurement and Data Quality Expert Committee and is a member of the 2025-2030 EC Pharmaceutical Analysis Lifecycle and Data Science. She was a member of the USP 2015-2020 Statistics Expert Committee. She has been Director of pharmaceutical Quality Control laboratories. She has experience with many different regulatory environments.   She is currently a consultant specializing in laboratory management systems, GMP testing, and ISO/IEC 17025. She is an auditor and an educator. Jane has applied Quality Systems and statistical techniques, including the evaluation and use of measurement uncertainty, in a wide variety of technical and scientific businesses. Recently she is focusing on the implementation of the new USP General Chapter 1220 Analytical Procedures Life Cycle. 

For too long, biotech innovators have viewed biological systems as inherently messy, unpredictable, and full of “black box” mysteries. But what if, armed with the latest digital tools, AI, and cross-disciplinary thinking, you could transform bioprocessing from a series of trial-and-error experiments to a streamlined, proactive design process?Carmen Jungo Rhême is Full Professor at the University of Applied Sciences in Fribourg (HEIA-FR) and Director of the Biofactory Competence Center (BCC). With 17 years in the pharmaceutical industry at companies like Lonza, Merck Serono, UCB Farchim, and CSL Behring, she specializes in bioprocess development, protein purification, scale-up, and technology transfer. Since joining HEIA-FR in late 2023, she has launched research projects tackling antimicrobial resistance, sustainable food production, and bioprocess digitalization.Here are three reasons why this episode is a must-listen:A Blueprint for Scalable Bioprocessing: Carmen reveals the structured, four-phase approach the BCC uses to help startups and established companies alike, from feasibility and risk assessment, to scalable process design, tailored analytics, and seamless tech transfer to GMP manufacturing.The Future-Proof Skill Set: Discover why data management, digital tool adaptability, and systems thinking are non-negotiable skills for biotech professionals in the next five years and how both newcomers and seasoned scientists can level up.Bioprocessing as Design, Not Chaos: Learn how shifting your mindset from reactive to proactive, and from “biology is messy” to “biology is designable,” can unlock robust processes, faster innovation, and truly sustainable solutions.Ready to smarten up your biotech game? Listen in as Carmen and David unpack practical, actionable strategies for mastering modern bioprocessing—no matter your starting point.Connect with Carmen Jungo Rhême:LinkedIn: www.linkedin.com/in/carmenjungoWebsite: www.heia-fr.ch/en/applied-research/bcc/Next step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

Almost every corner of modern medicine and sustainable food production today is facing a massive challenge: how do we outpace drug-resistant “superbugs” and create food for a growing population using fewer resources? The answer, it turns out, may come down to how well we understand and control the biomanufacturing processes underpinning these biomaterials and biomolecules.In this episode, David Brühlmann speaks with Carmen Jungo Rhême, Full Professor at the University of Applied Sciences in Fribourg, Switzerland and Director of the Biofactory Competence Center. With years in the pharmaceutical industry at Lonza, Merck Serono, UCB Farchim, and CSL Behring, she now tackles global challenges like antimicrobial resistance, sustainable food, and digitalization. From her beginnings in chemical engineering at EPFL to leading at the nexus of academia and industry, Carmen is helping shape the future of smarter, more robust biotech.Here are three reasons why this episode is a must-listen:Antimicrobial Resistance - Smarter Solutions: Carmen explains how phage therapy, recombinant proteins like endolysins, and smart bioprocess design are helping outmanoeuvre drug-resistant pathogens. In partnership with the University Hospital in Lausanne, her team is developing GMP-ready phage production using quality-by-design methods from mainstream recombinant protein manufacturing, bringing phages back into clinical relevance.From Cheese Whey to Microalgae: Applying pharma-grade principles to food, BCC is turning Swiss cheese by-products into nutrient-rich microalgae, offering a new path for sustainable protein and lipid production while transforming food waste into valuable resources.Digitalization - The Connecting Thread: Mapping and controlling hundreds of process parameters is key to robust, reproducible innovation. Carmen shows how data-driven process characterization links antimicrobial strategies and sustainable food production through the power of digital analytics.Curious about how smarter bioprocesses could help you solve tomorrow's biggest biotech challenges? Tune in to hear how Carmen's approach could transform your perspective on both health and food security.Connect with Carmen Jungo Rhême:LinkedIn: www.linkedin.com/in/carmenjungoWebsite: www.heia-fr.ch/en/applied-research/bcc/Next step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

Joe Ziolkowski, CEO of Relm Insurance delves into the evolving landscape of insurance for emerging and high-risk industries. They specifically addressed the significant insurance gaps for THC beverages and the prevalent underinsurance within the broader cannabis sector. Ziolkowski highlighted Relm Insurance's strategic diversification within the cannabis market, expanding its operations and achieving 50-state Managing General Agent (MGA) status to enhance accessibility and direct engagement with clients.The discussion also covered critical issues like climate change risks impacting cannabis cultivation, underscoring the necessity of robust data collection and compliance for accurate risk modeling and premium setting. Ziolkowski emphasized that meeting higher compliance standards, such as GMP, can lead to more favorable insurance terms. The conversation further explored the regulatory complexities of insuring new products like THC beverages, where traditional product liability may not suffice, and the nascent psychedelics industry, where Relm aims to facilitate business models by finding viable coverage solutions.We learn about Relm Insurance's deliberate expansion into the AI insurance sector, a move Ziolkowski explained as a natural progression due to the similarities in underwriting new and emerging risks, including data governance challenges and underdeveloped legislative frameworks. He also noted AI's potential to improve efficiency in cannabis, such as in precision farming.Ziolkowski concluded by stressing Relm's core vision of "making innovation resilient" and their long-term commitment to supporting forward-looking industries like cannabis, psychedelics, and AI, distinguishing them in the insurance market through their dedication to these sectors.Advertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy

In this episode of Let's ComBinate: Drugs + Devices, we welcome back Susan Neadle, author of The Combination Products Handbook. Susan explores the persistent and evolving challenge of terminology in combination products—a problem that continues to create confusion and regulatory risk even in 2025.Susan emphasizes the need for alignment on terminology and regulatory expectations, highlighting that true progress requires a science- and risk-based perspective. The discussion also covers how GMP requirements are interpreted differently in pharma versus medtech, the ongoing challenges of global harmonization, and why cohesive language is essential for compliance, inspection readiness, and effective product development.Episode Chapters00:00 Introduction and Welcome00:25 The Lexicon Problem in Drug-Device Combination Products01:01 Historical Efforts and Challenges02:12 Regulatory Frameworks and Definitions04:47 Industry and Regulatory Alignment Issues06:55 Science and Risk-Based Perspectives10:08 Terminology and Definitions in Practice14:05 Global Regulatory Differences17:22 Challenges in Harmonizing Standards23:13 Key Terms and Their Impact32:23 Conclusion and Contact InformationSusan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press. Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development. Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries. She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees. Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request. She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums. Susan can be reached at sneadle@combinationprod.com Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Superpowers for Good should not be considered investment advice. Seek counsel before making investment decisions. When you purchase an item, launch a campaign or create an investment account after clicking a link here, we may earn a fee. Engage to support our work.Watch the show on television by downloading the e360tv channel app to your Roku, LG or AmazonFireTV. You can also see it on YouTube.Devin: What is your superpower?Deepti: Persistence.Deepti Brambl, the founder of Kaylaan, is on a mission to revolutionize oral care while addressing environmental sustainability. Her innovative company is tackling the global issue of plastic waste with its unique toothpaste tablets, offering a game-changing alternative to traditional toothpaste packaged in plastic tubes.Kaylaan's toothpaste tablets are designed for simplicity and sustainability. “All you do is crunch it. Your saliva does the magic, and you just brush your teeth how you normally would,” Deepti explained. These tablets, made with clean ingredients, generate zero waste and do not require water for activation. They are an eco-friendly solution for environmentally conscious consumers.The journey to bring this product to market has been filled with challenges. Kaylaan is the first company in the United States to manufacture toothpaste tablets with fluoride, a key component for oral health. “We are the only company in the U.S. that manufactures toothpaste tablets with fluoride,” Deepti shared. Achieving this milestone involved navigating a complex FDA approval process, adopting good manufacturing practices (GMP), and undergoing rigorous testing.Deepti highlighted the financial hurdles her company has faced, particularly the annual FDA fees required for over-the-counter products with fluoride. “This year, we got a bill for $25,000 in FDA fees, and we know it will keep increasing. But we didn't stop,” she said, underscoring her determination to succeed.Kaylaan's product lineup includes several flavors tailored to different preferences, from mint to kid-friendly strawberry and watermelon, as well as neem, a nod to Deepti's Himalayan roots. The company recently expanded its offerings with mouthwash tablets, further advancing its mission to eliminate plastic waste.To scale its operations sustainably, Kaylaan is currently raising funds through a regulated investment crowdfunding campaign on Honeycomb Credit. Deepti views this community-driven approach as a way to grow without compromising the company's values. “We wanted to give back to our community and use the funds wisely to grow consistently,” she explained.Kaylaan is more than just a business—it represents a movement to rethink oral care and reduce the environmental footprint of daily routines. Deepti's vision and perseverance serve as an inspiring example of how innovative thinking can create impactful change.tl;dr:Kaylaan founder Deepti Brambl explains how plastic-free toothpaste tablets tackle waste and promote sustainability.Deepti shares challenges of FDA compliance and GMP certification as a small, self-funded startup.Kaylaan's innovative products include fluoride and non-fluoride options in five unique flavors.Deepti discusses raising capital via a regulated crowdfunding campaign to scale operations sustainably.Persistence and embracing failure are key to Deepti's success as a purpose-driven entrepreneur.How to Develop Persistence As a SuperpowerDeepti Brambl's superpower is persistence—a relentless determination to overcome challenges and achieve her goals. As she explained, “If I'm laser-focused and want to achieve something, that is something I would say is my superpower.” Deepti highlighted the role of failure in her journey, noting, “The superpower is failing a lot because that's where the real growth happens.” Her ability to embrace failure and keep moving forward has been key to her success as an entrepreneur.Illustrative Story:When Kaylaan faced an FDA audit, Deepti discovered the company wasn't fully compliant and received a 485 letter. This setback led Amazon to delist their products, forcing Kaylaan to pause operations temporarily. Instead of giving up, Deepti used the audit as a learning opportunity, hiring consultants and implementing rigorous compliance processes. The experience not only ensured full FDA compliance but also set Kaylaan on a path for long-term success.Tips for Developing Persistence:Embrace failure as an opportunity to learn and grow.Allow yourself time to process setbacks before tackling problems with a fresh perspective.Seek help and guidance from others when faced with challenges.Focus on long-term goals rather than immediate obstacles.Adopt the mindset that every problem has a solution.By following Deepti's example and advice, you can make persistence a skill. With practice and effort, you could make it a superpower that enables you to do more good in the world.Remember, however, that research into success suggests that building on your own superpowers is more important than creating new ones or overcoming weaknesses. You do you!Guest ProfileDeepti Brambl (she/her):CEO, Kaylaan About Kaylaan : Kaylaan manufactures Toothpaste Tablets and Mouthwash Tablets.Website: kaylaan.comX/Twitter Handle: @KaylaanTabsCompany Facebook Page: facebook.com/kaylaantoothpasteOther URL: invest.honeycombcredit.com/campaigns/KaylaanBiographical Information: Deepti Brambl, originally from the Himalayas, is the founder and lead engineer behind Kaylaan, a B Corp‑certified sustainable oral care company based in New York. Deepti has been featured in publications like Happi Magazine, Long Island Press, CanvasRebel, and on the “Founders, Unfiltered” podcast. On the Happi Podcast, she discussed Kaylaan's innovative approach to oral care and eco-packaging, positioning the brand at the intersection of sustainability and consumer convenience.Linkedin: linkedin.com/in/deeptibramblSupport Our SponsorsOur generous sponsors make our work possible, serving impact investors, social entrepreneurs, community builders and diverse founders. Today's advertisers include FundingHope, Rancho Affordable Housing (Proactive), Dopple, and Positive Polar. Learn more about advertising with us here.Max-Impact MembersThe following Max-Impact Members provide valuable financial support:Carol Fineagan, Independent Consultant | Hiten Sonpal, RISE Robotics | Lory Moore, Lory Moore Law | Marcia Brinton, High Desert Gear | Mark Grimes, Networked Enterprise Development | Matthew Mead, Hempitecture |  Michael Pratt, Qnetic | Dr. Nicole Paulk, Siren Biotechnology | Paul Lovejoy, Stakeholder Enterprise | Pearl Wright, Global Changemaker | Ralf Mandt, Next Pitch | Scott Thorpe, Philanthropist | Sharon Samjitsingh, Health Care Originals | Add Your Name HereUpcoming SuperCrowd Event CalendarIf a location is not noted, the events below are virtual.Impact Cherub Club Meeting hosted by The Super Crowd, Inc., a public benefit corporation, on August 19, 2025, at 1:30 PM Eastern. Each month, the Club meets to review new offerings for investment consideration and to conduct due diligence on previously screened deals. To join the Impact Cherub Club, become an Impact Member of the SuperCrowd.SuperCrowdHour, August 20, 2025, at 12:00 PM Eastern. Devin Thorpe, CEO and Founder of The Super Crowd, Inc., will lead a session on "Your Portal, Your Future: How to Choose the Right Reg CF Platform." With so many investment crowdfunding portals available today, selecting the right one can be overwhelming for both founders and investors. In this session, Devin will break down the critical factors to consider—such as platform fees, audience demographics, compliance support, industry focus, and overall user experience. Whether you're a founder planning a raise or an investor exploring where to put your dollars to work, you'll walk away with a clearer understanding of how to evaluate and choose the platform that best aligns with your goals. Don't miss this practical, insight-packed hour designed to help you take your next step in the Reg CF ecosystem with confidence.SuperCrowd25, August 21st and 22nd: This two-day virtual event is an annual tradition but with big upgrades for 2025! We'll be streaming live across the web and on TV via e360tv. VIPs get access to our better-than-in-person networking, including backstage passes, VIP networking and an exclusive VIP webinar! Get your VIP access for just $25. A select group of affordable sponsorship opportunities is still available. Learn more here.Community Event CalendarSuccessful Funding with Karl Dakin, Tuesdays at 10:00 AM ET - Click on Events.NEIGHBR Live Webinar, in partnership with FundingHope, will share NEIGHBR's story with a wider audience — September 3 at 11 AM EST. Reserve your spot today!Regulated Investment Crowdfunding Summit 2025, Crowdfunding Professional Association, Washington DC, October 21-22, 2025.Impact Accelerator Summit is a live in-person event taking place in Austin, Texas, from October 23–25, 2025. This exclusive gathering brings together 100 heart-centered, conscious entrepreneurs generating $1M+ in revenue with 20–30 family offices and venture funds actively seeking to invest in world-changing businesses. Referred by Michael Dash, participants can expect an inspiring, high-impact experience focused on capital connection, growth, and global impact.If you would like to submit an event for us to share with the 9,000+ changemakers, investors and entrepreneurs who are members of the SuperCrowd, click here.We use AI to help us write compelling recaps of each episode. Get full access to Superpowers for Good at www.superpowers4good.com/subscribe