Smart Biotech Scientist | Bioprocess CMC Development, Biologics Manufacturing & Scale-up for Busy Scientists

Send us a textIs an Indian CDMO the right move for your biologics CMC development?Pulling back the curtain on what might be your next strategic manufacturing advantage, this episode reveals the hidden capabilities emerging from India that leading biotech companies are racing to access. As supply chain vulnerabilities continue to expose risks in traditional manufacturing models, could the solution lie halfway around the world?Joining us to reveal the inside story is Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions and veteran of global pharma giants like Bayer, Merck and Lonza. With over 20 years in biotech, Abdelaziz brings unique insights on when and why you might want to look beyond traditional Western manufacturing partners. Our host, David Brühlmann, leverages his 15+ years of biotech industry experience to extract the practical insights you need to make informed decisions about your manufacturing strategy.In this second segment, we'll dive deeper into the Indian CDMO and biomanufacturing landscape. Then we'll explore Lupin's specialized capabilities and finally extract Abdelaziz's most valuable leadership insight from his role as a CEO.Key insights from this episode:The One-Stop Solution Advantage: Discover how Lupin is building rare end-to-end manufacturing capabilities for complex modalities like Antibody-Drug Conjugates (ADCs) - potentially eliminating the headache of managing multiple manufacturing partners across continents.Beyond Labor Cost Advantages: "Digitalization plays a key role, especially if you are operating in a cost-competitive space," explains Abdelaziz. Learn how Indian CDMOs are strategically automating key processes to drive both efficiency and quality, challenging Western perceptions.Leadership Across Cultures: "Listen, listen, listen," emphasizes Abdelaziz when discussing cross-cultural leadership. Understand the subtle communication dynamics that can make or break a global manufacturing partnership, especially when navigating hierarchy-sensitive cultures.Whether you're actively evaluating Indian manufacturing options or simply preparing for the shifting global biotech landscape, these next several minutes deliver insights you can't afford to miss.Listen to the full episode to extract the specific capability indicators that will help you determine if and when an Indian CDMO partnership makes strategic sense for your unique biologics pipeline.Want to find out more about the CDMO selection? Here's what one of our distinguished guests had to say about it:Episodes 103-104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma MostafaConnect with Abdelaziz Toumi:LinkedIn: www.linkedin.com/in/abdelaziztoumiLupin Manufacturing Solutions: www.lupin.comNext step:Transform your process development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textIs an Indian CDMO the right move for your biologics pipeline?As Western biotech companies seek new strategic advantages, one question keeps surfacing: Is India truly becoming the next biotech manufacturing powerhouse? And what hidden capabilities are emerging that leading companies are racing to access?In this episode of the Smart Biotech Scientist Podcast, Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions and veteran of global pharma giants like Bayer, Merck, and Lonza, joins host David Brühlmann to reveal the inside story on when and why you might want to look beyond traditional Western manufacturing partners.Here are three key insights from their conversation:The Post-Pandemic Manufacturing Revelation: "During the pandemic, we realized how vulnerable our supply chain truly is," explains Abdelaziz. Discover why diversifying manufacturing partnerships isn't just smart—it's becoming essential for resilience in an unpredictable world.Beyond the Cost Advantage: While Indian CDMOs can deliver up to 80% cost savings compared to Western counterparts, Abdelaziz reveals the unexpected advantages that make the most strategic partnerships about far more than budget considerations.The Trust Factor: "This is a business of trust," emphasizes Abdelaziz. Learn the critical questions that separate world-class Indian CDMOs from the rest, and the cultural nuances that can make or break your manufacturing partnership.Ready to discover if Indian CDMOs could be the missing piece in your biologics development strategy? Tune in for expert insights on IP protection, talent access, and how to navigate the cultural dynamics that determine success in this emerging manufacturing powerhouse.Listen to the full episode to unlock the strategic advantage that could transform your pipeline's journey from lab to market.Want to find out more about the CDMO selection? Here's what one of our distinguished guests had to say about it:Episodes 103-104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma MostafaConnect with Abdelaziz Toumi:LinkedIn: www.linkedin.com/in/abdelaziztoumiLupin Manufacturing Solutions: www.lupin.comNext step:Transform your process development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textAs biotech labs rush to adopt AI tools for cell culture media development, a critical question emerges: Are we creating a generation of scientists who know which buttons to push but not why they're pushing them? The automation trap that once transformed laboratory workflows now threatens to fundamentally alter how we understand the complex dynamics of culture media composition and performance.In this second part of our conversation with Tom Fletcher, R&D Director at Fujifilm Irvine Scientific, host David Brühlmann explores the practical challenges of implementing AI in cell culture media development while preserving the scientific thinking that drives true innovation.Key Insights from Their Conversation:The Knowledge Generation Imperative: "Don't just think of your job as picking winners out of random experiments," Tom warns. He emphasizes that scientists must prioritize understanding why a specific media formulation works, not just that it works—a distinction that becomes critical as AI makes high-throughput media screening increasingly accessible.Bridging Disciplinary Divides: As teams become more diverse—incorporating data scientists, automation specialists, and traditional bioprocess experts—success depends on creating a collaborative culture where specialists learn to leverage each other's strengths without expecting everyone to have the same foundation in cell culture fundamentals.The Future Bioprocessing Landscape: Tom predicts that while platform media will dominate for speed to clinic, human roles will evolve toward managing automated, digitalized processes with fewer but more technically specialized staff. The media developers who thrive will be those who can maintain scientific rigor while harnessing the power of automation.For biotech leaders navigating this technological transition, Tom's advice is clear: "Embrace AI because I think we all believe it's valuable, but don't allow lazy science to creep in... if you don't resist it, people are going to get lazy and just say 'I've got this supercomputer and I know which buttons to push.' That's not good enough."If you enjoyed this conversation, be sure to explore how it all began:Episodes 1-2: Unlock the Power of Rational Media Design in Bioprocessing with Tom FletcherConnect with Tom Fletcher:LinkedIn: www.linkedin.com/in/tomfletcher2FUJIFILM Irvine Scientific: www.irvinesci.comThe views and opinions expressed by Tom Fletcher are his own and do not necessarily reflect those of Fujifilm Irvine Scientific or its affiliates.Next step:Transform your cell culture media development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotechNote: These are Tom's personal opinions and not his company's.

Send us a textFrom closely-guarded secrets to complex chemical interactions, cell culture media development has transformed from an afterthought to a critical competitive advantage in modern bioprocessing. But as AI and automation revolutionize the field, are we at risk of gaining speed while losing understanding?In this eye-opening episode of the Smart Biotech Scientist Podcast, host David Brühlmann speaks with Tom Fletcher, R&D Director at Fujifilm Irvine Scientific, who brings over 30 years of experience and a unique perspective on balancing technological innovation with scientific rigor.Key Insights from Their Conversation:The Evolution of Media Formulations: Tom traces the remarkable journey from basic serum supplements to today's chemically defined media with 60-70+ precisely balanced components, transforming what was once "just that stuff you bought" into one of bioprocessing's most closely guarded competitive advantages.The Collaborative Intelligence Framework: The most powerful approach combines artificial intelligence with human intelligence (AI + HI = CI), where technology enhances rather than replaces scientific thinking to generate not just data, but genuine process understanding.Avoiding the Automation Trap: "Don't get lazy with technology," Tom warns, emphasizing that the goal remains generating knowledge about why processes work, not just identifying which conditions perform best—a crucial mindset as companies increasingly adopt powerful AI tools.If you enjoyed this conversation, be sure to explore how it all began:Episodes 1-2: Unlock the Power of Rational Media Design in Bioprocessing with Tom FletcherConnect with Tom Fletcher:LinkedIn: www.linkedin.com/in/tomfletcher2FUJIFILM Irvine Scientific: www.irvinesci.comThe views and opinions expressed by Tom Fletcher are his own and do not necessarily reflect those of Fujifilm Irvine Scientific or its affiliates.Next step:Transform your cell culture media development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textIn the wake of the COVID-19 pandemic, the fragility of global blood supply systems became undeniably clear. Recognizing the urgent need for a more reliable and universal solution, Ari Gargir and his team at RedC Biotech are leading an ambitious effort to transform blood supply as we know it. Their mission? To develop lab-grown red blood cells that not only address chronic shortages but also overcome blood type compatibility - an innovation with the potential to reshape modern medicine.As the CEO and founder of RedC Biotech, Ari brings a powerful personal story to this mission. After a near-fatal paragliding accident, a life-saving transfusion ignited his determination to create a scalable, donor-free blood alternative. Now, through pioneering bioprocessing techniques, he and his team are working to produce universal red blood cells that could serve nearly anyone, anywhere.In this episode, we explore:Bioprocessing Breakthroughs: How RedC Biotech transforms stem cells into red blood cells - scaling from lab flasks to industrial bioreactors - and the key challenges in making this process scalable and cost-effective.Quality and Cost Challenges: The rigorous standards for safety, efficacy, and affordability, and how RedC Bioteh is tackling them to produce viable blood units at scale.Why Now? - Ari shares why this moment is uniquely suited for breakthroughs in blood biotech, thanks to recent advancements in Induced pluripotent stem cell (iPSC) technology and hard lessons learned from COVID-19.Listen to the full episode for Ari's insights and advice for biotech entrepreneurs navigating bold, high-impact innovations.Connect with Ari Gargir:LinkedIn: www.linkedin.com/in/ari-gargir-7107035RedC Biotech: www.redcbiotech.comNext step:Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textBlood is critical to global healthcare - vital for surgeries, trauma care, cancer treatment, and maternal health. Yet despite 120 million donations each year, a 100 million unit shortfall means nearly half the world's needs go unmet.One person who understands this crisis firsthand is Ari Gargir, CEO & Founder of RedC Biotech. After surviving a paragliding accident thanks to a life-saving transfusion, he set out to tackle the global blood shortage. His team is now developing universal, lab-grown red blood cells, eliminating the need for donors.The added transitional phrase creates a smoother flow between the global problem and the personal story that follows.Don't miss these key insights from the full conversation:The Global Crisis: Ari painted a vivid picture of the current state of blood supply. The problem is multifaceted - logistical issues, biological challenges, and socio-economic disparities in blood distribution exacerbate this shortage. Developed nations possess more blood resources, but low-income countries, where donation rates are staggeringly low, continually grapple with severe shortages.Innovative Solutions: We learned about the groundbreaking technology Ari is developing at RedC Biotech. Using stem cells, they aim to create unlimited, universal, and donor-free red blood cells. This could be a game-changer, not only for transfusions but also for advanced therapeutic uses.Impact on Healthcare: Ari is a strong advocate for O-negative blood, which can be used for up to 98% of people. But he's especially focused on vulnerable patients - those with sickle cell disease, thalassemia, and complex immune conditions - who may need frequent transfusions.Our conversation with Ari underscores the importance of innovation in biotechnology to address critical global healthcare issues. By creating a reliable, scalable supply of red blood cells, RedC Biotech holds the promise of saving countless lives and improving the quality of life for those dependent on regular blood transfusions.Tune in to hear how Ari and RedC Biotech are shaping the future of transfusion medicine.Connect with Ari Gargir:LinkedIn: www.linkedin.com/in/ari-gargir-7107035RedC Biotech: www.redcbiotech.comNext step:Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textStuck with outdated analytics while trying to develop cutting-edge therapies? Part 2 of our conversation with Bruno Oesch, CEO and founder of Elionova, reveals how biotech scientists can finally break free from incremental improvements and embrace the revolutionary immunoassay technology that's transforming bioprocessing workflows worldwide.For years, ELISA (Enzyme-Linked Immunosorbent Assay) has been vital in biotechnology, but its time-consuming protocols and complex washing steps slow bioprocess development, creating bottlenecks in advancing therapies.Bruno's team is transforming the field of immunoassays with an innovative technology that delivers quantitative results in just 10 minutes—without the need for washing steps.Here are three key takeaways from the conversation:Market Introduction Strategy: Bruno emphasizes the importance of placing the product directly in the hands of potential customers. By offering free trials, users can experience its value firsthand, creating a strong incentive for continued use.Building an Open Community: Elionova fosters a collaborative environment where users can develop and share assays. Their vision follows an app store model, encouraging innovation and knowledge exchange within the biotech space.Vision for the Future: Beginning with research labs, Elionova aims to expand into diagnostics, particularly in veterinary medicine, due to lower regulatory hurdles. Their long-term goal is to make a significant impact in point-of-care diagnostics, offering rapid results crucial for emergency medical scenarios.If you're a biotech professional looking to streamline bioprocess workflows and drive innovation, Bruno Oesch's transformative approach may provide the inspiration you need. Stay ahead of industry advancements by tuning into this episode to learn more about connecting with Oesch and exploring Elionova's novel technology.Connect with Bruno Oesch:LinkedIn: www.linkedin.com/in/bruno-oeschElionova: www.elionova.comNext step:Ready to revolutionize your bioprocess workflows? Book a free consultation at https://bruehlmann-consulting.com/call to discover how real-time analytics can transform your development timeline.

Send us a textTired of waiting overnight for ELISA results? Serial entrepreneur Bruno Oesch reveals how his groundbreaking 10-minute immunoassay technology is eliminating the biggest bottleneck in bioprocessing workflows.From contributing to Nobel Prize-winning prion research to founding Prionics (the first commercial BSE test) and now revolutionizing immunoassays with Elionova, Bruno transforms high-end science into practical solutions that work for everyday labs.Here are three takeaways from this podcast episode:ELISA - The Lab Workhorse That Still Matters: Since the 1970s, ELISA assays have been a cornerstone of bioprocessing and diagnostics. As Bruno Oesch puts it, they remain the "workhorses of biochemical labs." Despite requiring over four hours of binding and washing steps, ELISA remains widely used for its affordability and reliability. However, its slow, linear workflow calls for innovation.ElioDX - The Next-Gen Immunoassay: While Elionova didn't invent evanescence, they've made it accessible and practical. Instead of lengthy washes, a laser-generated evanescent field enables real-time detection, delivering results in just 10 minutes by measuring signal changes dynamically.The Future of Real-Time Bioprocessing: This breakthrough eliminates bottlenecks in biotech workflows. By integrating real-time analysis, ElioDX enhances efficiency, decision-making, and continuous bioprocessing, ensuring precise insights exactly when they're needed.As David and Bruno highlight, the future of immunoassays isn't just about innovation - it's about making these advancements practical and transformative across the industry.By bridging science and accessibility, leaders like Bruno Oesch play a crucial role in demystifying bioprocessing, sparking impactful discussions, and driving real change in the scientific community.Listen to the full discussion to explore how this real-time approach can streamline bioprocessing and transform your workflows.Connect with Bruno Oesch:LinkedIn: www.linkedin.com/in/bruno-oeschElionova: www.elionova.comNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech

Send us a textImagine a future where every patient can access life-saving therapies and sustainable, high-quality food is within everyone's reach. In this episode of the Smart Biotech Scientist, David Brühlmann explores how innovative biotech developments are making this vision a reality.Here's a sneak peek of the breakthroughs covered:AI-Powered Picoliter Scale Testing: Discover how companies like Triple Bar Bio are pushing the boundaries of what's possible with their innovative microfluidic technology that screens individual cells. Their approach enables rapid identification the best cell producers, paving the way for more efficient and precise bio-manufacturing.Hybrid Models for Process Prediction: Learn about DataHow's cutting-edge hybrid models that predicts process outcomes and improves product quality. Their models have demonstrated the potential to reduce the number of experiments by up to 80%.Unconventional Bioreactor Approaches: Explore an intriguing proposition – could tomorrow's bioreactors be living organisms like goats? BioSourcing is exploring the potential of transgenic goats to produce biopharmaceuticals more affordably, a concept that could dramatically lower production costs and enhance accessibility.The future of biotech is not just about technological advancement; it's about embracing the impact these innovations can have globally. As David urges, the challenge is no longer about if these changes will happen, but how quickly we can achieve them.Stay curious, keep innovating, and be part of this exciting transformation in biotech. Your contributions and feedback could shape the next generation of breakthroughs.Listen, learn, and let us know what you think about these advancements. We can't wait to hear from you!If you enjoyed this, here are some episodes worth listening:Episode 135: Beyond Breakthroughs: Making Biotherapeutics Affordable for AllEpisode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)Episodes 127-128: The 7 Hidden Innovation Habits That Top Biotech Scientists Use DailyEpisode 87: The Hidden Pitfalls of Bioprocess Development: Lessons from the TrenchesEpisodes 41-42: Revealing the Disciplined Pursuit of Less in BioprocessingNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/callDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech

Send us a textIn the rapidly evolving world of biotechnology, innovation is not just happening at the molecular level. Industry leaders are making groundbreaking advancements in bioprocessing - a crucial component in making life-saving therapies more accessible and affordable.The journey to affordable therapies starts with the production process itself. In this podcast episode, David Brühlmann sheds light on innovations in bioprocess design that are setting new standards in efficiency and efficacy. At the heart of this transformation is the shift from traditional process formats like fed-batch to continuous process formats, quality by design approaches, and the implementation of breakthrough technologies.Here's a quick rundown of the key takeaways:Revolutionary Process Designs: Industry leaders are enhancing bioprocess designs—from antibody production enhancements to integrating perfusion mode. One case study highlighted a dramatic increase in viable cell density and protein titers through intensified processes.Quality Control Innovations: Companies like Cyto-Facto are pioneering quality by design in the challenging cell and gene therapy space. By leveraging sophisticated PAT systems, they can monitor critical process parameters in real-time, ensuring consistent quality even in complex bioprocesses.Metabolite Shifts and Efficacy: A surprising discovery revealed the power of metabolite shifts induced by cell culture media design, inspired by an intriguing study on cyclists, to enhance antibody efficacy and stability. This opens new possibilities for engineering the quality of biopharmaceuticals through simple modifications in the culturing process.The innovations discussed in the Smart Biotech Scientist illustrate a pivotal transformation in bioprocessing. By rethinking process designs and committing to quality control, the biotech industry is paving the way for groundbreaking therapies that are not just dreams but realities - realities that are tangibly more accessible to patients worldwide.As we anticipate more developments in this field, the promise of biotech becomes increasingly certain: a future where life-saving treatments are affordable and available to all who need them.Catch the full episode to explore how these innovations are not just improving efficiency but making life-saving therapies more accessible globally.If you enjoyed this, here are some episodes worth listening:Episode 135: Beyond Breakthroughs: Making Biotherapeutics Affordable for AllEpisode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)Episodes 127-128: The 7 Hidden Innovation Habits That Top Biotech Scientists Use DailyEpisode 87: The Hidden Pitfalls of Bioprocess Development: Lessons from the TrenchesEpisodes 41-42: Revealing the Disciplined Pursuit of Less in BioprocessingNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/callDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech

Send us a textWhat if we could revolutionize biotechnology by slashing antibody production costs by 70%? In a world where traditional mammalian cell cultures struggle with scalability and cost-effectiveness, an unexpected hero emerges from the depths of our oceans - microalgae.The use of microalgae in biotechnology is not just a novelty but a necessity, given the current demands for more efficient and cost-effective production methods. Muriel Bardor, co-founder, CEO and CSO of Alga Biologics, highlights a particularly startling statistic: microalgae can reduce the cost of antibody production by an impressive 70%. This innovation could revolutionize the biotechnology industry by making life-saving therapies more accessible.Here are 3 key takeaways from this podcast episode:Quality and Safety Assurance: By collaborating with virology experts and using advanced techniques like mass spectrometry, they ensure that their processes are virus-free and free from host-cell protein contamination. The company is paving the way for future developments despite the challenges of not having standard ELISA kits commercially available.Regulation and Industry Perception: Launching such transformative technology inevitably entwines with regulatory landscapes. Muriel and her company have begun discussions with the French regulatory agency, drawing optimism from the fact that similar plant-based products, such as glucocerebrosidase, have already paved the way in the market. This indicates a growing acceptance within regulatory bodies of alternative bioprocessing platforms, inspiring hope for microalgae's future in antibody production.Future Vision: Muriel hopes to break conservative barriers within pharmaceutical companies and promote the adoption of microalgae production. This offers not only cost-effective solutions but also holds potential for new treatment options, like for neuroblastoma.Check out the episode to hear Muriel's advice for aspiring scientists and the general public alike regarding the future of research and the well-being of our planet.Connect with Muriel Bardor:LinkedIn: www.linkedin.com/in/muriel-bardor-47953024Email: muriel.bardor@univ-rouen.frAlga Biologics: www.algabiologics.comNext step:Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech

Send us a textThe world of biologics manufacturing is about to be transformed by a breakthrough that slashes antibody production costs by 70%. This revolutionary approach leverages the untapped potential of microalgae to deliver a sustainable, cost-effective solution that could make life-saving therapeutics more accessible than ever before. Enter microalgae, the star of this groundbreaking development.In this episode of the Smart Biotech Scientist, Muriel Bardor, the co-founder, CEO and CSO of Alga Biologics, shared insights into how her team's pioneering work with microalgae could redefine the landscape of immunotherapy.Here are some takeaways from her conversation with David Brühlmann:Green Revolution in Bioprocessing: Discover how microalgae can slash production costs by 70% and offer a sustainable alternative to traditional antibody manufacturing. Muriel explains how these photosynthetic organisms capture 7 tons of CO2 per kilogram of product - transforming antibody manufacturing both economically and environmentally.Rethinking Antibody Production: Learn why the conventional use of mammalian cells in antibody production is being challenged and how microalgae overcome the limitations of traditional methods, bringing life-saving drugs within reach for more people globally.Sustainable Impact: With a process that mirrors nature, Muriel's approach sets a new standard for eco-friendly biotech production. Find out how microalgae are changing not just the industry, but our world.We invite you to listen to this insightful conversation and explore how you can apply these groundbreaking ideas to your own work. Has Muriel's innovative approach inspired you? Share your thoughts or questions with us - we'd love to hear from you!If you are interested in antibody production, here is another episode worth listening:Episodes 47-48: Mastering Process Economics: Driving Down Costs in Antibody Production with Brian KelleyConnect with Muriel Bardor:LinkedIn: www.linkedin.com/in/muriel-bardor-47953024Email: muriel.bardor@univ-rouen.frAlga Biologics: www.algabiologics.comNext step:Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech

Send us a textIn this episode, we explore the important steps in preparing for regulatory meetings, address the dangers of cross-contamination in biotechnology facilities, and debunk common misconceptions that could derail your CMC development strategy.As the founder and president of ADRES - Advanced Regulatory Services Ltd., Rivka Zaibel brings over 36 years of industry experience and practical strategies to help navigate the intricacies of CMC development and regulatory compliance.Here are three key takeaways:Risk Assessment is Paramount: Start risk assessments in parallel with facility design to prevent cross contamination. Remember, areas for both mammalian and microbial cells should be segregated to ensure safety.Early Engagement with Regulatory Agencies: Don't wait until everything is finalized before consulting with regulatory bodies. Engaging them early can ensure your plans align with their requirements and might even spark valuable advice you hadn't considered.Understand and Plan Your Product Journey: Have a clear vision of your final product from the start, and plan backwards. This approach ensures all supporting processes are adequately addressed, saving time and preventing costly mistakes down the line.Ultimately, successful biologics development hinges on thorough understanding and strategic planning. This includes comprehensive risk assessments, early regulatory engagement, and a commitment to continuous training and facility validation.Rivka's insights offer a roadmap for navigating this complex landscape, aiming to deliver groundbreaking therapies with precision and compliance. By following these expert strategies, biotech professionals can streamline their processes, avoid common pitfalls, and ensure the successful introduction of their products to the market.Connect with Rivka Zaibel:LinkedIn: www.linkedin.com/in/rivka-zaibel/ADRES - Advanced Regulatory Services Ltd.: www.adres.bioEmail: tanya@adres.bioNext step:Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech

Send us a textIn biotherapeutic drug development, the journey from discovery to clinic involves navigating a labyrinth of regulatory requirements and strategic considerations, particularly in Chemistry, Manufacturing, and Control (CMC).In this episode of the Smart Biotech Scientist, host David Brühlmann engaged with Rivka Zaibel, President and Founder of ADRES - Advanced Regulatory Services Ltd. - to demystify the regulatory intricacies of biologics development and provide actionable insights for biotech leaders.With over three decades of experience in the biopharmaceutical industry, Rivka Zaibel highlights that understanding the regulatory landscape is crucial for the success of biologics development.Here are three key takeaways from this episode:Prioritize CMC Development Early: CMC (Chemistry, Manufacturing, and Controls) development is crucial in biologics. Rivka emphasizes starting early and engaging with regulatory agencies to avoid costly delays and streamline the bioprocessing journey.Understand Regulatory Differences: Different agencies (FDA vs. EMA) may have varied interpretations of guidelines. Familiarize yourself with ICH guidelines and the specific requirements of each agency to align your strategy effectively.Leverage Existing Resources: Before developing your own product pathway, explore existing European Public Assessment Reports (EPARs) and summary bases of approval for comparable products. This research can provide valuable insights into regulatory expectations and streamline your approach.For startups navigating the complexities of CMC development, Rivka highlights three critical quality and regulatory considerations essential for reaching Phase 1 trials. By embracing these key insights, biotech professionals can streamline the path to delivering innovative therapies to patients safely and efficiently.In conclusion, as you continue your journey within the biopharmaceutical industry, let the Smart Biotech Scientist serve as your guide, demystifying the complexities and empowering you with the tools needed to thrive. Stay informed, stay proactive!Connect with Rivka Zaibel:LinkedIn: www.linkedin.com/in/rivka-zaibel/ADRES - Advanced Regulatory Services Ltd.: www.adres.bioEmail: tanya@adres.bioNext step:Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech

Send us a textIn the fast-evolving world of biotechnology, the pursuit of efficiency and faster development has never been more critical. The computational tools and models currently being integrated into bioprocessing present a groundbreaking approach that promises radical shifts in drug development timelines and capabilities.In the second part of our conversation, Yossi Quint, founder and CEO of Ark, shows us that the horizon of bioprocessing is lined with possibilities that could revolutionize biotherapeutics accessibility, cost, and speed in pharmaceutical innovations.Here are three key takeaways you don't want to miss:De-risking with Simulation: Yossi shared how simulation models can drastically reduce risks by running many scenarios before actual implementation. This approach optimizes processes, lowers costs, and speeds up the development cycle.Transfer Learning in Bioprocessing: Discover the potential of leveraging data across different types of molecules! Although challenging, the ultimate goal is to apply data learnings from one process to others, maximizing efficiency and success rates.Patient Impact & Cost Reduction: At the heart of these innovations is the goal of quicker, more affordable drug production. By slicing down on both time and costs, computational tools not only help drugs reach the market faster but also make them more accessible to patients globally.With innovation at its core, the modern trajectory of bioprocessing is not simply about reaching scientific milestones but about profoundly transforming patient care and accessibility. This synergistic blend of technology and purpose crafts a future in which the biotechnology sector not only grows but also enriches countless lives around the globe.If you are interested in this topic, here are a few standout conversations on AI's impact on bioprocessing with some incredible experts:Episodes 131-132: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza FarahaniEpisodes 115-116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy AgrestiEpisodes 111-112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars BrandénEpisodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David SchönauerEpisodes 95-96: AI in Bioprocess Development: The Game-Changer You Can't Ignore with Belma AlispahicConnect with Yossi Quint:LinkedIn: https://www.linkedin.com/in/yossi-quintArk: https://www.ark-biotech.comNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textThe integration of AI into drug discovery has already led to groundbreaking advancements, uncovering patterns in vast datasets that were previously invisible to human researchers. Now, AI is set to revolutionize bioprocessing as well.In this episode of the Smart Biotech Scientist Podcast, Yossi Quint, founder and CEO of Ark, and David Brühlmann explore how AI and computational tools are reshaping bioprocess development. Yossi envisions a future where 90% of bioreactor experiments could be replaced by in silico simulations, dramatically accelerating time to market and increasing throughput.Key takeaways from the conversation with Yossi Quint:AI's Role in Drug Discovery & Bioprocessing: AI is already transforming drug discovery by identifying intricate patterns across millions of data points. Now, bioprocessing is undergoing a similar revolution, as computational tools simplify and streamline complex workflows.The Power of Hybrid Models: Yossi highlights the synergy between mechanistic models and AI-driven approaches, emphasizing how AI can fill gaps where traditional models struggle—especially in understanding complex cellular behaviors.Empowering Bioprocess Teams with AI: As AI accelerates drug discovery, bioprocessing must evolve to keep pace. Yossi discusses the importance of digital transformation in ensuring bioprocess teams can meet increasing demands and drive innovation forward.With AI-driven models, hybrid simulations, and increased digitization, the bioprocessing industry stands at the cusp of a new era. The convergence of data, science, and technology promises not only greater efficiency and accuracy but also a faster path to life-saving treatments for patients in need.If you want to learn more, here are a few standout conversations on AI's impact on bioprocessing with some incredible experts:Episodes 131-132: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza FarahaniEpisodes 115-116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy AgrestiEpisodes 111-112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars BrandénEpisodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David SchönauerEpisodes 95-96: AI in Bioprocess Development: The Game-Changer You Can't Ignore with Belma AlispahicConnect with Yossi Quint:LinkedIn: https://www.linkedin.com/in/yossi-quintArk: https://www.ark-biotech.comNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textSickle cell disease, a genetic disorder affecting thousands, presents a daily struggle akin to having shards of glass tearing through one's veins. Despite breakthrough gene therapies approved by the FDA, the prohibitive cost of $2.2 million per treatment limits their accessibility.In the latest episode of the Smart Biotech Scientist Podcast, host David Brühlmann discusses five critical challenges the bioprocessing industry must overcome to make these life-saving therapies accessible to a broader population.Moving Away from Platform TechnologiesTraditional bioprocessing has relied heavily on platform technologies, particularly in the production of antibodies. This conventional method involves cultivating cells in bioreactors, predominantly CHO cells, followed by a series of purification steps. This well-established process is now being disrupted by new modalities that cannot adhere to this template. As the industry progresses, creating flexible and scalable systems compatible with novel therapies becomes essential.Increased Personalization and Smaller Batch SizesThe rise of personalized medicine is another formidable challenge. Treatments like autologous cell therapy, which involves extracting and cultivating the patient's cells before reintroducing them, require highly customized approaches. Each patient essentially represents a batch size of one, making automation difficult and leading to manual, paper-driven processes. This shift from large-scale manufacturing to smaller, lab-like settings demands innovation in bioprocessing equipment and methodologies to maintain efficiency and quality.Cultivating Sensitive CellsAs bioprocessing diversifies, the cultivation of increasingly sensitive cells has become a significant hurdle. Unlike the robust CHO cells, newer cell types require gentler handling and innovative bioreactor designs. Startups like Kolibri, Biothrust, and Green Elephant Biotech are pioneering novel bioreactor technologies to address these needs. From acoustic wave bioreactors to stress-free cultivation conditions and minimal-space cell screws, these innovations aim to provide the optimal environment for sensitive cells to thrive.The Cell as the ProductThe complexity of the products has exponentially grown. While an antibody weighs roughly 150 kDa, a single cell weighs a staggering 10 to the power of 14th Da, making it a billion times more massive. This increase in complexity translates to heightened production challenges, monitoring, and quality control to ensure each cell-based product meets therapeutic standards. The industry must develop refined processes and technologies to manage and scale the production of these intricate cellular products effectively.Accessibility and Cost ChallengesPerhaps the most pressing issue is the prohibitive cost of advanced therapies. Despite the existence of revolutionary treatments for conditions like severe asthma and sickle cell disease, the high price tags render them inaccessible to most patients globally. For instance, in the CAR T cell therapy space, only 21,000 out of an estimated 900,000 eligible patients have received treatment due to financial constraints. Addressing these cost barriers is crucial to expanding the reach of these life-saving therapies.Innovative Approaches and Collaborative EffortsAs discussed in the podcast, industry leaders from academia, small companies, and big pharma are actively seeking solutions to these challenges. Collaborative efforts are essential to drive innovation and reduce manufacturing costs. By focusing on scalable, cost-effective, and high-quality production methods, the industry can move towards wider accessibility of advanced therapies. Ensuring that breakthroughs in bioprocessing translat

Send us a textIn a world of rapid advancements in medical science and biotechnology, bioprocessing is at the forefront of healthcare innovation. Yet, despite remarkable progress, life-saving biotherapeutics remain out of reach for much of the global population.A staggering 80% of patients worldwide lack access to the biotherapeutics they need. While bioprocessing has made impressive strides, the high cost and slow development of these treatments create significant barriers. Addressing these challenges is critical to making innovative therapies widely available.David Brühlmann is launching a special four-part series based on his keynote at the Amphacademy, exploring bioprocessing's revolutionary journey - from the early days of recombinant insulin to today's groundbreaking therapies. This series will also highlight strategies to make these innovations more accessible to patients worldwide.From Standardization to PersonalizationOne major challenge is the shift away from platform technologies. Traditionally, antibodies were produced using standardized CHO cell templates and purification steps, but this approach falls short for new modalities.Personalized therapies further complicate the landscape. Autologous cell therapies, for example, require isolating, cultivating, and reinfusing a patient's own cells. These small-batch processes are labor-intensive, less automated, and often reliant on outdated, paper-driven workflows.Innovations in Bioreactor DesignWith the rise of sensitive cell therapies, bioreactor design must evolve. Unlike CHO cells, these delicate cells require gentler handling environments. Innovations like acoustic wave bioreactors, bionic bioreactors, and specialized cell screws are emerging to optimize cell growth and improve efficiency.The Complexity and Cost of Cell-Based ProductsNew bioprocessing modalities bring greater complexity. Cell-based therapies and cultivated meats are far more intricate than traditional antibody proteins, making scaling production and ensuring quality especially challenging.High production costs further limit access. Even in regions where these therapies are approved, pricing remains a major barrier. Lowering manufacturing costs is essential to democratizing these life-saving treatments.The shift from basic recombinant proteins to complex cell-based therapeutics is just the beginning. Overcoming these challenges - scaling production, reducing costs, and managing complexity - is key to making breakthrough therapies accessible to all.Next step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textThe biotechnology industry is on a transformative path. With emerging technologies and innovative ideas, bioprocessing professionals are poised to revolutionize how therapies are developed and delivered. In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann continues his conversation with François Carruzzo, the CTO of Bioscibex, as they delve into the challenges and opportunities present in the biotech landscape.Bioprocess automation boosts efficiency and scalability in therapeutic production. François Carruzzo explores how automation and sensors simplify processes, cut costs, and enhance reliability - key to making biologics more accessible worldwide.Here are some key lessons Carruzzo learned on his entrepreneurial journey:Seeking and Leveraging Advice as a Startup: For biotechnology entrepreneurs, seeking the right advice is a cornerstone for success. Carruzzo discusses the significance of having a scientific advisor. He highlights the value of external perspectives in helping startups navigate strategic decisions, addressing complex challenges, and innovating effectively.The Role of Networking and Ecosystems: Startup ecosystems and networks play an indispensable role in propelling innovations within the biotech industry. Situated in Lausanne, Switzerland, Bioscibex is well-positioned within a dynamic biopharma ecosystem. Utilizing incubators and networking events, Carruzzo underscores the importance of connecting with other innovative organizations and experts, which can accelerate product development and industry relevance.Customer Engagement as a Key Driver for Innovation: Understanding and integrating the voice of the customer is pivotal in product development. Carruzzo emphasizes starting customer interactions early in the development process. Engaging with potential users before launching a prototype allows companies to tailor products that meet user needs and align with market demands.Carruzzo advises biotech entrepreneurs to validate their ideas through market research and pursue them with commitment. He highlights the challenges of innovation but emphasizes its invaluable rewards. By streamlining processes and prioritizing innovation, the biotech industry can drive progress that benefits both companies and patients worldwide.This episode highlights how breakthrough biotech innovations require strategy, regulatory expertise, and customer focus. Bioscibex's journey exemplifies technology's transformative power in the industry.Want to dive deeper into the startup journey and gain insights from entrepreneurs?Episodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian GuoEpisodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David SchönauerEpisodes 83-84: The Hidden Potential of Shake Flasks: What Every Biotech Scientist Needs to Know with Jens BayerEpisodes 81-82: Regenerating Muscles: The Future of Autologous Cell-based Therapy with Deana MohrConnect with François Carruzzo:LinkedIn: https://www.linkedin.com/in/francois-carruzzoBioscibex: https://bioscibex.comNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhu

Send us a textBiologics manufacturing relies heavily on optimizing various stages, yet the seed train step - often overlooked - plays a critical role in determining overall efficiency. The seed train involves expanding cells from a small working cell bank to scales suitable for production bioreactors.Francois Carruzzo, Co-founder and CTO of Bioscibex, is rethinking how this process can be simplified, streamlined, and made more reliable, using a fully automated, closed system. However, the complexity of scaling introduces several risks, including handling errors, contamination, and delays that could derail production timelines.Today, seed train processes involve multiple vessels, open handling, and labor-intensive steps, all of which complicate operations. François identified two prominent challenges:Contamination Risks: Multiple open steps, such as using spin tubes, shake flasks, and wave systems, result in a heightened potential for contamination.Operational Complexity: With multiple campaigns and products running simultaneously, accommodating different media types and containers can become overwhelming.Bioscibex is on the verge of revolutionizing seed train operations with its innovative single-use bioreactor system. François shared how this system addresses traditional shortcomings:Wide Turndown Ratio: Capable of scaling from 30 mL all the way to 30 L within the same vessel, Bioscibex's rocking motion reactor eliminates multiple intermediary steps.Closed Workflow: By maintaining a fully enclosed environment, the system dramatically lowers contamination risks, making bioprocessing more reliable.Continuous Cell Expansion: Unlike traditional methods that involve batch dilutions, Bioscibex supports continuous cell expansion, ensuring optimal growth conditions with reduced downtime.Innovation in seed train processes extends far beyond mere operational efficiency. It lays the groundwork for scalable, consistent biologics production, ensuring therapies can reliably reach clinics faster.By simplifying the mundane yet critical seed train step, his innovation offers a glimpse into the future of stress-free, scalable cell expansion - a vision we're excited to see unfold.Interested in finding out more about the progress made in cell culture? Take a listen to what our previous guests had to say about it:Episodes 117-118 - Critical Bottlenecks and Breakthroughs in Cell Line Development with Andrea GoughEpisodes 113-114: Weighing of Single-Use Bag Systems: Why Traditional Load Cells Are Holding You Back with Anders TvegaardEpisodes 109-110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier DetournayConnect with François Carruzzo:LinkedIn: https://www.linkedin.com/in/francois-carruzzoBioscibex: https://bioscibex.comNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textArtificial Intelligence (AI) is transforming industries worldwide, and biotechnology is no exception. In bioprocess development, AI is proving to be a game-changer, accelerating workflows, optimizing processes, and driving innovation. On the Smart Biotech Scientist Podcast, Reza Farahani, founder and CEO of Catalyze AI, shares his insights on how AI is reshaping biomanufacturing and the future of the industry.As AI continues to integrate into bioprocessing, the role of scientists is evolving. Farahani envisions a future where scientists collaborate with AI to enhance efficiency. One of Catalyze AI's exciting innovations is an agentic root cause analysis tool, designed to automate troubleshooting. Instead of spending hours on manual analysis, scientists will receive AI-generated reports outlining probable causes of failures—allowing them to focus on high-level decision-making.What you'll learn in this episode:Exciting Advances in AI: Farahani highlights the potential of Artificial General Intelligence (AGI)—AI that can generate ideas through analogy, much like humans do. Imagine an AI system recognizing a successful method in the petroleum industry and applying those principles to biomanufacturing. This kind of cross-disciplinary innovation could unlock groundbreaking efficiencies.Leadership Principles in AI-Driven Biotech Startups: Farahani takes an unconventional approach to leadership. Unlike corporate environments where avoiding mistakes is crucial, he encourages his team to embrace failure early on. "I want to see you make a mistake in the first month," he tells new hires. By removing the fear of failure, his team can experiment, think creatively, and drive true innovation—an essential mindset for biotech startups breaking new ground.Advice for Aspiring Biotech Entrepreneurs: Farahani's advice is simple: find a problem, develop a unique solution, and take action. He urges scientists to identify small inefficiencies that can be scaled and optimized. Equally important is being open to failure and iterating quickly to refine solutions. Success comes from starting, adapting, and continuously improving.As we stand on the brink of a biomanufacturing revolution, the real opportunity lies in combining AI with biologics. While AI often dominates the conversation, Farahani emphasizes that biologics remain underhyped. The true breakthroughs will come from leveraging AI to solve real-world challenges in biomanufacturing, leading to significant efficiencies and industry-wide advancements.For those passionate about this field, staying connected with thought leaders like Reza Farahani and keeping up with the latest innovations is key. As AI and biologics continue to converge, the future of bioprocessing holds unprecedented potential for transformation and progress.Curious about how AI is transforming bioprocessing? Discover how industry experts are driving innovation to shape the future of this field.Episodes 111 and 112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars BrandénEpisodes 107 and 108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David SchönauerConnect with Reza FarahaniLinkedIn: https://www.linkedin.com/in/reza-farahani-/Catalyze AI: https://www.catalyzeai.com/Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call.

Send us a textThe real-world applications of AI in biomanufacturing are transformative. From reducing drug development timelines to optimizing production yields, AI is making biomanufacturing more efficient and cost-effective. This, in turn, enhances global access to life-saving therapies. As AI continues to evolve, its potential to drive even greater innovations in biologics manufacturing becomes increasingly promising.In the latest episode of the Smart Biotech Scientist Podcast, David Brühlmann speaks with Reza Farahani, founder and CEO of Catalyze AI, about the profound impact of AI on biomanufacturing. They discuss how AI is reshaping drug development, reducing costs, and simplifying complex biomanufacturing processes - bringing us closer to a future where life-saving drugs are as accessible as smartphones.Why You Should Tune In:AI's Role in Democratizing Biomanufacturing: One of the core missions of Catalyze AI is to democratize the sophisticated knowledge that currently resides mostly within top pharmaceutical companies. By leveraging AI to improve bioprocess development, Farahani aims to bridge the knowledge gap between academia and industry, thereby reducing the cost and accelerating the development of new therapeutics. This democratization of bioprocess knowledge could potentially revolutionize the accessibility and affordability of life-saving drugs.How AI Optimizes Bioprocess Development: AI has the unique ability to manage and analyze complex, convoluted data sets much more efficiently than humans. Reza explains how transformer models—similar to the ones used in natural language processing tasks by ChatGPT—can be utilized to predict and optimize various steps in the biomanufacturing process. These models can learn and make predictions based on past data, enabling a significant reduction in the time and resources required for process development.Solving the Scale-Up Challenge: Scale-up remains one of the most challenging aspects of bioprocess development, often plagued by delays and inefficiencies. AI can immensely help by leveraging data from both small and large-scale biomanufacturing processes to predict optimal conditions. However, given the complexity and high cost associated with scale-up experiments, Reza envisions a future where distributed, small-scale biomanufacturing units could replace large-scale facilities. This would not only reduce costs but also enhance flexibility and resilience against process failures.AI is not just accelerating drug development—it's reshaping the entire biomanufacturing landscape. Don't miss this insightful conversation on how AI is driving the future of biotech.As we stand at the intersection of AI and biomanufacturing, the possibilities are limitless. With continued advancements, we may soon witness a paradigm shift where drug production becomes more decentralized, efficient, and tailored to global healthcare needs. The future of biotech is being written now—are you ready to be part of it?Interested in exploring more about AI's impact on bioprocessing? Check out what other experts in the field are doing to drive innovation in this space.Episodes 119 and 120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian GuoEpisodes 115 and 116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy AgrestiConnect with Reza FarahaniLinkedIn: https://www.linkedin.com/in/reza-farahani-/Catalyze AI: https://www.catalyzeai.com/Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success:

Send us a textThe intricacies of tech transfer and the challenges of scaling manufacturing processes are often underestimated in the biotechnology industry. Understanding these complexities is crucial for translating innovative scientific breakthroughs into commercially viable products.In the second part of the conversation with Jason Foster, CEO of Ori Biotech, host David Brühlmann explores the complexities of cell therapy manufacturing. Their discussion highlights key challenges, including tech transfer, scale-out strategies, and the crucial role of commercial strategy alongside scientific excellence.Jason also revealed a groundbreaking approach in the cell therapy space. He detailed how Ori's IRO® platform can process multiple patient doses simultaneously, enabling treatment for 30 patients in parallel within just 1,000 square feet of clean room space. This innovative method drastically reduces clean room requirements by about 95% and facility sizes by approximately 50%, significantly cutting costs associated with building and operating large-scale facilities.As Jason emphasized, this shift not only accelerates access to groundbreaking therapies but also provides a sustainable model for scaling cell therapy production.Key Points to Remember:Integrated Approach: Scientists should look beyond their specialized areas and understand the requirements of subsequent bioprocessing stages to maximize patient impact.Technological Evolution: Advancing distributed manufacturing and enhancing in-line analytics are essential steps to revolutionize the biotech landscape.Commercial Viability: Prioritizing commercial feasibility alongside safety and efficacy in preclinical development can prevent costly late-stage setbacks.This episode of the Smart Biotech Scientist underscores the complexities and transformative potential of cell therapy manufacturing. As the industry continues to innovate, integrating commercial viability, flexibility, and advanced manufacturing solutions will be critical. By breaking down silos and fostering collaboration, we can accelerate the development of life-saving therapies—ensuring they reach patients faster and more efficiently.Connect with Jason FosterLinkedIn: https://www.linkedin.com/in/jasoncfosterOribiotech: https://oribiotech.comWondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textOne of the most urgent challenges in modern medicine is making cell and gene therapies widely accessible. These therapies, while groundbreaking in their safety and efficacy, often fall short when it comes to reaching patients. The reasons are manifold—high manufacturing costs, logistical complexities, and inefficiencies in the production pipeline.We're joined by Jason Foster, CEO and Executive Director of Ori Biotech, a company that's revolutionizing cell and gene therapy manufacturing through automation and innovative approaches.Jason sheds light on the technical bottlenecks that limit patient access to life-saving therapies and discusses how an integrated, holistic view of the development chain could make a significant difference. From the complexities of centralized manufacturing and the interconnectedness of the supply chain, to specific technical solutions Ori Biotech has developed, we explore the multi-faceted issues and potential solutions in making these advanced therapies more reachable.Here are three key takeaways from our conversation:Holistic Development Chain: Jason emphasizes the importance of integrating all stakeholders in the development chain, ensuring everyone understands what happens before and what needs to happen next to improve the overall process.Technical Bottlenecks & Solutions: We delved into various technical bottlenecks, including centralized manufacturing and logistical complexities. Jason highlighted how Ori Biotech is addressing these issues through automation and reducing manual labor, which can cut manufacturing costs by 50%.Impact on Accessibility: It's alarming that only 3-5% of patients who need CAR-T therapies have access to them. Jason's mission with Ori Biotech is to transform this narrative by enabling widespread access to these life-saving therapies through innovative manufacturing solutions.As cell and gene therapies stand poised to revolutionize cancer and rare disease treatment, the focus must shift toward overcoming manufacturing constraints. By integrating automation and aiming for decentralized models, companies like Ori Biotech offer a glimpse into a future where these revolutionary treatments are accessible to all who need them.Fascinated by Cell Therapy? Hear from top experts in these two episodes!Episodes 11 and 12: From Lab to Patient: Steve Oh's Guide to Mastering Cell Therapy Process DevelopmentEpisodes 21 and 22: Unleashing Effective QbD Strategies to Master Cell Therapy with Shin KawamataConnect with Jason FosterLinkedIn: https://www.linkedin.com/in/jasoncfosterOribiotech: https://oribiotech.comWondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textThe world of bioprocess development in biotechnology is evolving at an unprecedented pace, driven by the quest for breakthrough innovations. While new technologies play a significant role, what truly sets successful innovators apart are fundamental habits that foster an environment ripe for groundbreaking discoveries.In today's discussion, we'll delve into three essential habits that, when combined with the four habits previously discussed, can redefine your approach to bioprocess development. Additionally, we'll wrap up with a bonus tip that has the potential to revolutionize your career.Challenge the Status Quo - In any scientific endeavor, particularly in biotech, a common pitfall is accepting established processes as the best or only methods. The fifth habit to cultivate is the continuous challenging of the status quo. When was the last time you scrutinized your standard operating procedures and wondered why they are the way they are?Embrace Continuous Learning - Innovation in biotech is characterized by rapid advancements, and staying ahead demands continuous learning. According to a 2023 EDX survey, nearly half of today's workplace skills will be obsolete by 2025, primarily due to AI advancements. Hence, the sixth habit is to never stop learning.Harness the Power of Passion - At the core of every great innovation is passion. The seventh habit revolves around the deep sense of purpose that drives scientific pursuits. Beyond the routine aspects of bioprocess development, what truly fuels your ambition?Finally, a game-changing career strategy known as Strategic Cross-Pollination Networking can significantly enhance your innovative capabilities. This goes beyond traditional networking, focusing on building connections across various domains to foster innovative solutions.Innovation in bioprocess development is not about daily eureka moments but about the consistent application of these habits. Small, persistent efforts can cumulatively lead to transformative results in this rapidly evolving field.If you found these insights valuable, share them with your colleagues. Ready to fast-track your product and technology development? As a strategic advisor to biotech leaders, we can help you eliminate costly delays and optimize your path to market.Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textIn the fast-paced and highly regulated world of biotech development, maintaining an innovative spirit can sometimes feel like a Herculean task. Between optimizing cell culture processes and navigating strict regulatory requirements, it's no wonder many scientists feel the weight of daily operations pressing down on their creativity. However, fostering innovation is crucial for breakthroughs in our field.David Brühlmann shares practices that have transformed how scientists approach complex challenges in our field.Here are the first four habits that can reshape your approach to bioprocess development.Cultivate Deep Curiosity: Curiosity is the cornerstone of scientific discovery. However, it's not just about a broad interest in science. The type of curiosity that drives innovation is the kind that goes beyond initial observations. It's the kind that makes you question what's happening inside the cell culture and strive to understand phenomena at a fundamental level.Connect the Dots: Innovation often comes from connecting seemingly unrelated ideas. Drawing connections between different facts or events can lead to a better understanding and new approaches to complex challenges.Embrace Calculated Risks: In a GMP environment, risk-taking may sound contradictory. However, calculated risks are essential for innovation. It's about carefully evaluating opportunities and understanding their potential impact before acting.Practice Persistence: Persistence is a key ingredient for innovation, especially during challenging times. Experimentation often involves setbacks and unexpected results, but each failure is a learning opportunity.Fostering innovation in biotech development is a multifaceted process that requires curiosity, the ability to connect dots, calculated risks, persistence, collaboration, digital tools, and continuous learning. By integrating these habits into your work routine, you can unlock new potentials and drive breakthroughs in the biotech field. Remember, breakthroughs often come from embracing the complex nature of bioprocess development and continuously exploring, questioning, and innovating.Don't miss our next episode, where we'll reveal the final three habits!Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textAs biotechnology rapidly evolves, cell therapies are emerging as a groundbreaking frontier with the potential to transform medicine. In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann speaks with Armon Sharei, founder and CEO of Portal Bio, about the complexities, challenges, and future of cell therapies.Cell therapies could revolutionize medicine in ways similar to antibiotics and vaccines. However, the current manufacturing process is costly and time-consuming.Armon Sharei envisions a future where point-of-care production makes these therapies more accessible, even at the patient's bedside. This approach could not only benefit developed countries but also emerging markets.Armon suggests that cell therapies could be as transformative as antibiotics and vaccines, with the potential to address complex diseases like cancer and autoimmune disorders. These therapies could precisely target tumors, correct dysfunctions in autoimmune diseases, and regenerate tissues in conditions like Parkinson's.Key Takeaways:Cell Therapies as the Future: Armon emphasizes that cell therapies, like antibiotics and vaccines, offer high efficacy with minimal toxicity. They can address complex diseases such as tumors and autoimmune disorders.Simplifying Manufacturing: Current manufacturing methods are expensive and slow. Portal Bio's point-of-care approach could streamline production, reducing both time and costs.Expanding Accessibility: Making cell therapies more accessible requires technological advances as well as changes in regulatory and quality standards to lower costs and make treatments available globally.As technology advances, the future of cell therapies looks promising. Armon believes point-of-care cell therapies will bring sophisticated treatments directly to patients, transforming healthcare.Connect with Armon ShareiLinkedIn: https://www.linkedin.com/in/armonsharei/Portal: https://www.portal.bioWondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textIntracellular delivery is essential for advancing research and clinical applications, yet it presents unique challenges when working with different cell types and biomolecules.In a recent episode of the Smart Biotech Scientist podcast, David Brühlmann spoke with Armon Sharei, the founder and CEO of Portal Bio, about the future of cell therapy, the hurdles of intracellular delivery, and groundbreaking innovations in drug screening.Armon's journey began at MIT, where his initial focus on chemical engineering evolved into a passion for cell engineering. While exploring innovative methods for introducing materials into cells, he discovered a novel mechanism: squeezing cells to temporarily disrupt their membranes, allowing materials to diffuse in.Armon explained that optimizing delivery parameters - such as pore size and the speed at which cells pass through specialized membranes - can significantly enhance efficiency. "If you've optimized it, one time is enough," he noted. "We can get above 80% delivery and viability pretty easily for most cell types." He emphasized the importance of tailoring pore sizes to specific cell types, such as smaller pores for T cells compared to stem cells. Additionally, the flow speed of cells through the membrane is critical; moving too slowly renders the process ineffective, while moving too quickly can damage the cells.Tune in to this episode to find out more about:Addressing Intracellular Delivery Challenges: Portal Bio's breakthrough technology uses mechanical deformation to open a cell's lipid bilayer, allowing materials to diffuse in. This approach overcomes the limitations of traditional methods like electroporation or nanoparticle-mediated delivery, which often depend on molecular charge or risk damaging cells.Delivering a Wide Range of Molecules: Portal Bio's technology is versatile, capable of delivering DNA, RNA, peptides, proteins, and more. Unlike methods tailored to specific molecules, this platform supports diverse applications. For instance, RNA operates in the cytoplasm, making delivery straightforward, while CRISPR complexes require nuclear localization sequences to enable gene editing in the nucleus.Streamlining Drug Screening: Portal Bio's technology also revolutionizes drug screening. Traditional approaches often struggle with impermeable small molecules, leading to lengthy and uncertain drug development processes. By enabling high-throughput screening, Portal Bio accelerates the evaluation of numerous drug candidates, identifying promising options before chemical modifications are necessary.As bioprocesses grow more advanced, the demand for efficient and versatile intracellular delivery methods becomes increasingly critical. Armon's insights underscore a transformative shift in the technologies and processes shaping the future of cell therapy and bioprocessing.Connect with Armon ShareiLinkedIn: https://www.linkedin.com/in/armonshareiPortal: https://www.portal.bioWondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textIn part two of our insightful conversation, Dr. Susan Sharfstein builds on our previous discussion of developability assessment to explore how AI is revolutionizing protein manufacturability predictions.As a Professor of Nanoscale Science and Engineering at the University of Albany, she shares groundbreaking insights from her collaboration with DeepSeq AI, demonstrating how artificial intelligence is transforming our ability to assess and predict protein manufacturability early in development.Key Takeaways:Discover how AI tools are enhancing traditional developability assessments by predicting protein expression and stability before entering the labLearn why integration of experimental validation with AI predictions is crucial for successful manufacturability assessment, and how industry partnerships are making this possible at unprecedented scaleUnderstand how the synergy between AI, DNA synthesis capabilities, and robotics is creating a "positive spiral" that will accelerate protein manufacturing innovationWhether you're involved in candidate selection, process development, or curious about AI's impact on developability assessment, this episode offers valuable insights into the future of protein manufacturing. Plus, Dr. Sharfstein shares invaluable career advice for emerging biotech scientists.Join us to explore how AI is reshaping developability assessment and learn why this field continues to offer life-changing possibilities for patients worldwide.Connect with Susan Sharfstein:LinkedIn: https://www.linkedin.com/in/susan-sharfstein-b7552111/College of Nanotechnology, Science, and Engineering, University at Albany: https://www.albany.edu/cnseNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textIn this eye-opening episode, we dive deep into the critical yet often overlooked world of protein manufacturability with Dr. Susan Sharfstein, Professor of Nanoscale Science and Engineering at the University of Albany. As part of the broader developability assessment process, manufacturability evaluation helps determine whether a therapeutic candidate can be successfully produced at commercial scale.Drawing from her extensive experience in bioprocessing and cell culture technology, Dr. Sharfstein reveals why seemingly promising protein candidates can fail during manufacturing—and how to spot these issues early.Key Takeaways:Discover why efficacy isn't enough: Learn how to evaluate protein candidates beyond clinical performance to ensure manufacturing successMaster early-stage assessment: Understand the critical parameters that can make or break successful scale-up, from cell line selection to protein foldingFuture-proof your development: Gain insights into how AI is transforming protein manufacturability assessment and what this means for process developmentWhether you're selecting protein candidates or optimizing your bioprocess, this episode offers invaluable guidance for making smarter decisions earlier in development. Join us to learn how to bridge the gap between discovery and manufacturing success.Listen now to transform how you approach protein manufacturability and save valuable time and resources in your development journey.Connect with Susan Sharfstein:LinkedIn: https://www.linkedin.com/in/susan-sharfstein-b7552111/College of Nanotechnology, Science, and Engineering, University at Albany: https://www.albany.edu/cnseNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textIn the second part of this conversation on digital solutions in bioprocessing, David Brühlmann and Simon Wieninger, Business Manager Digital Solutions at Eppendorf Group, discuss real-world examples of labs revolutionizing their workflows through smart digitalization. From real-time data monitoring to intercontinental data sharing, Simon highlights the practical benefits and exciting future potential of digital technologies in bioprocessing.Missed Part 1? In the previous episode, Simon Wieninger from Eppendorf Group addressed data silos, cloud technology, and security in biotech. Catch up on that episode before diving into Part 2!Key highlights from the episode:Choosing the Right Tools: Simon emphasized the importance of selecting the right digital tools and technologies to focus on what brings the most value, particularly in the bioreactor space. Real-time data access, even from your mobile device while walking your dog, is now possible!Data Sharing Across Sites: Simon shared a fascinating case where a U.S.-based biotech company and their CDMO in Germany shared real-time data through the cloud, breaking down silos and enabling collaborative analysis. Imagine the possibilities for your company!Looking to the Future: We explored the exciting potential of integrating bioprocessing data with clinical outcomes, particularly in cell and gene therapy. This holistic approach can revolutionize patient care and therapy development.As Simon succinctly puts it, scientists should focus on what they do best - biology. The burden of managing digital technologies should not overshadow their primary research and development activities. With specialized tools and expert support, biotechnologists can achieve greater efficiency and innovation without getting bogged down by technological complexities.The conversation between Simon Wieninger and David Brühlmann illuminates the transformative potential of digital tools in bioprocessing. From real-time monitoring to data harmonization and cross-site collaboration, these technologies are paving the way for more efficient and innovative bioprocessing practices.By strategically adopting these tools, scientists can focus on groundbreaking research, ultimately accelerating the development and delivery of life-saving therapies.Connect with Simon Wieninger:LinkedIn: https://www.linkedin.com/in/dr-simon-wieninger-45b546182Eppendorf Group: https://www.eppendorf.comNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a textDigital transformation is reshaping industries worldwide, and biotech is no exception. With the integration of cloud technologies, AI, and data harmonization, bioprocessing is becoming smarter, more efficient, and more innovative. Catching up with digital revolutions in other sectors, biotech now stands at the threshold of tremendous change.In this episode of the Smart Biotech Scientist Podcast, David Brühlmann sat down with Simon Wieninger, Business Manager Digital Solutions at Eppendorf Group, to discuss the digital revolution sweeping through bioprocessing labs. From bioreactors to data lakes, Simon sheds light on the urgent need for a data-driven approach in biotech and how digital transformation is set to reshape the industry.Here are the top three key takeaways:Breaking Down Silos: The importance of consolidating data in one place to facilitate better analysis and collaboration across departments.Leveraging Cloud Technology: Simon emphasized that the biotech industry is ready to embrace cloud technologies for enhanced data management.Data Security Concerns: Addressing the common misconception about cloud security, Simon reassured that robust measures are in place to protect bioprocess data, making it as secure as banking data.The move towards centralized data storage, the integration of AI, and strategic collaborations are critical steps in this journey. The industry is poised for transformation, and as Simon aptly put it, “step by step,” we can harness the full potential of these digital solutions. As biotech continues to evolve, the fusion of technology and biological science will undoubtedly lead to groundbreaking advancements, streamlining processes, and unlocking new possibilities in the field.Connect with Simon WieningerLinkedIn: https://www.linkedin.com/in/dr-simon-wieninger-45b546182Eppendorf Group: https://www.eppendorf.comEnjoyed this episode? Don't miss these related discussions:Episode 100: From Raw Data to Actionable Insights: Unlocking the Power of Process Models with Fabian Feidl, co-founder and CTO of DataHowEpisode 05: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov, the co-founder and COO of DataHowNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a textIn the ever-evolving world of biotechnology, the integration of artificial intelligence (AI) and synthetic biology is driving unprecedented advancements. This transformative power was the focus of this podcast episode of the Smart Biotech Scientist, where host David Brühlmann engaged in a thought-provoking conversation with Haotian Guo, CEO and Founder of Ailurus on the role of AI in bioprocessing, the significance of wet lab validation, and the exciting future of programmable biology.The conversation with Haotian Guo sheds light on the profound impact AI is having on the field of biotechnology. AI's role as a "co-pilot" in scientific endeavors has enabled researchers to tackle complex problems with greater efficiency and accuracy. Haotian Guo shares: "AI helps us tremendously with tasks that are tedious and time-consuming for humans, such as reading and summarizing vast amounts of scientific literature. This capability allows scientists to focus on higher-order thinking and problem-solving."Key insights for this conversation:AI as Co-Pilot: Discover how Ailurus leverages AI to enhance research workflows. Haotian emphasizes using AI to read and analyze massive amounts of scientific literature, making it an invaluable co-pilot in the lab.Synthetic Biology Meets AI: Learn how synthetic biology combined with AI-driven models is opening new horizons for developing DNA designs and optimizing protein engineering. This fusion of biology and technology is proving to be a game-changer.Challenges in Biotech: Haotian candidly discusses the ongoing challenges, such as the need for wet lab validation and the high costs associated with data generation. Despite these hurdles, the potential for AI to streamline processes is immense.While the integration of AI and synthetic biology offers tremendous opportunities, Haotian Guo advises caution, particularly for those considering venturing into a biotech startup. He acknowledges the high-risk nature of startups, especially in an unpredictable economic landscape.However, he also underscores the importance of perseverance and preparedness, qualities crucial for navigating the biotech industry's challenges.In conclusion, Haotian Guo's insights paint a compelling picture of the future. The synergy between AI and biotech holds the promise of smarter, more efficient, and more accessible scientific research. By leveraging the strengths of both computational and experimental approaches, the biotech community is poised to achieve remarkable breakthroughs, transforming the landscape of healthcare and beyond.Connect with Haotian Guo:LinkedIn: www.linkedin.com/in/haotian-guoAilurus: www.ailurus.bioNext Steps:Wondering how to develop bioprocesses with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a textBiotechnology is rapidly evolving as innovation addresses real-world needs. At the cutting edge of this evolution, synthetic biology and AI-driven protein design are revolutionizing our approach to complex processes like protein purification.In this episode of the Smart Biotech Scientist podcast, host David Brühlmann talks with Haotian Guo, CEO and Founder of Ailurus, about the modern advancements in synthetic organelles and their transformative impact on protein purification.Haotian Guo introduces a groundbreaking approach inspired by nature's processes. Instead of relying solely on chromatography, synthetic biology mimics how organelles in cells, like beta cells purifying insulin, naturally segregate and process proteins. This innovation simplifies and optimizes bioprocessing, offering a more efficient alternative to traditional techniques.Key takeaways from this conversation:Revolutionary Advances in Protein Purification: Haotian discusses the innovative use of synthetic membrane-less organelles to simplify and enhance protein purification processes, drawing inspiration from natural cellular mechanisms.Combining AI with Synthetic Biology: Learn how the integration of AI and biotechnology can accelerate advancements and create more efficient bioprocesses, unlocking potential for rapid development in biologics.Scalability and Practical Applications: Insight into how these new technologies are being scaled from lab environments to industrial applications, maintaining high purity and yield, and the potential roadblocks and solutions encountered along the way.Through innovation rooted in imitation of natural processes and amplified by the power of AI, the future of protein purification looks drastically simplified, more efficient, and scalable. Synthetic organelles represent a leap forward, challenging the age-old techniques that have long dominated the field.Companies like Ailurus are not just contributing new tools but reshaping the roadmap for bioprocess development. As we stand on the brink of these technological advancements, the collaborative synergy between synthetic biology and artificial intelligence is setting the stage for revolutionary impacts across the biotech landscape.This podcast episode is filled with eye-opening insights and practical takeaways for anyone in the biotech or pharmaceutical industries. Whether you're an academic, a seasoned industry professional, or simply curious about the field, you'll find valuable perspectives to explore.Connect with Haotian Guo:LinkedIn: www.linkedin.com/in/haotian-guoAilurus: www.ailurus.bioNext Steps:Wondering how to develop bioprocesses with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a textIn the second part of our conversation with Andrea Gough, Senior Director for Advanced Instruments' Solentim Portfolio, we'll explore how AI and machine learning have, in recent years, begun to transform various aspects of biotechnology, including cell line development (CLD). Andrea shares insights into how these cutting-edge technologies are being applied to the early stages of clone selection.AI's capability to analyze images and classify clone viability is another breakthrough. Feeding thousands of images into AI systems allows for efficient and accurate decision-making, reducing the workload on scientists.Here are three key takeaways from our conversation:Leverage AI and Machine Learning: Integrate AI to streamline clone selection and optimize cell line development processes. AI can identify key phenotypic identifiers and predict the best clones, driving efficiency and productivity.Diversify Expression Systems: While CHO cells dominate the protein therapy space, exploring alternative systems like HEK cells, MSCs, IPSCs, and even insect cells can offer unique benefits and improve gene therapy productions.Maintain Comprehensive Documentation: Ensure rigorous tracking and documentation of all processes. From certificates of analysis to raw image data, having meticulous records will safeguard your development process and aid compliance with regulatory standards.Tune in to the full episode for more insights on overcoming challenges in cell line development and tips for setting up successful bioprocessing workflows!Connect with Andrea GoughLinkedIn: www.linkedin.com/in/andrea-gough-72915282Advanced Instruments: www.aicompanies.comNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a textCell line development (CLD) is a cornerstone of biologics production. This intricate process involves establishing a cell line capable of consistently producing a desired product, such as a therapeutic protein. While advancing science has refined numerous aspects of CLD, bottlenecks still exist, perpetuating challenges for scientists and industry professionals.In this episode of the Smart Biotech Scientist Podcast, Andrea Gough, Senior Director for Advanced Instruments' Solentim Portfolio, shared her extensive insights into the critical bottlenecks and innovative breakthroughs in cell line development.Here are three key takeaways from this episode:Understanding the DNA Integration Complexity: Andrea discusses the pros and cons of random integration, highlighting how it can become a bottleneck. She emphasizes the importance of choosing the right methodology from the very beginning to avoid the "needle in a haystack" scenario when searching for a good clone.Modern Tools for Ensuring Clonality: Technologies like imaging devices and single-cell dispensers have revolutionized the process. Learn about the shift from traditional limiting dilution methods to more sophisticated and efficient tools that provide better evidence for regulatory approval.Innovative Approaches to Accelerate Development: Discover how semi-targeted integration methods like transposon technology can significantly shorten timelines and improve clone stability. Andrea also explores the use of bulk pools to generate initial products quickly for pre-clinical and initial clinical studies.Developing cell lines is a complex process, but with advanced tools and innovative approaches, challenges can become opportunities. As biotechnology progresses, the ability to stay informed and flexible will remain essential for success.Catch the full episode to gain deeper insights and practical advice for advancing your cell line development projects!Join us for the next episode featuring Andrea Gough, as we explore how AI and machine learning are being integrated into the early stages of clone selection. This groundbreaking approach is transforming key areas of biotechnology, including cell line development (CLD).Connect with Andrea Gough:LinkedIn: www.linkedin.com/in/andrea-gough-72915282Advanced Instruments: www.aicompanies.comNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a textThe intersection of artificial intelligence and biology presents immense opportunities for transforming bioprocess development. As the biotech industry continues to evolve, data-driven innovations are critical to optimizing biologics manufacturing. High-quality datasets stand at the forefront of this transformation, empowering researchers to make informed predictions and advance therapeutic discoveries. As AI tools become more commoditized, the focus shifts toward generating robust and extensive datasets to maximize the potential of machine learning in biological applications.Miniaturization has emerged as a vital enabler in this data-driven approach. Miniaturized systems allow researchers to conduct thousands of tests in an area no larger than the palm of your hand. This drastic reduction in material and resource requirements makes high-throughput screening feasible, economical, and scalable.Traditional liquid handling robots can manage thousands of tests per day, but each test requires considerable amounts of material, usually leading to high costs. Conventional systems can cost anywhere from $10 to $100 to get a single genotype sequence from discovery to sequencing. Miniaturization can bring these costs down to mere pennies per data point, making it possible to scale the dataset size exponentially.Key takeaways from our discussion:The future of AI in biology relies heavily on large, well-annotated datasets. Without them, the full potential of AI remains untapped. High-quality data enables more accurate predictions of protein structures and functions.Success in bioprocess development often involves collaboration with partners across the value chain. By working together, companies can leverage their unique strengths and expertise to overcome barriers and innovate more efficiently.Advancements in miniaturization technology allow for high throughput screening at reduced costs. This shift makes it viable to generate large datasets, speeding up the pace of discovery and making AI-driven predictions more accessible.This episode is essential for anyone eager to explore the transformative fusion of AI and biotechnology. Jeremy Agresti highlights the future of bioprocessing at the intersection of high-throughput screening, miniaturization, and AI, revealing how these innovations are solving complex challenges, driving breakthroughs, and shaping the future of science and medicine.Connect with Jeremy Agresti:LinkedIn: www.linkedin.com/in/jeremy-agresti-88546850/Triplebar: www.triplebar.comNext Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Learn more at https://bruehlmann-consulting.com

Send us a textBioprocess development is transforming the biotech industry, driving innovations in life-changing therapies. Success hinges on simplifying complex mechanisms and adopting advanced technologies. By integrating high-throughput screening and artificial intelligence, we can streamline workflows, reduce trial-and-error, and speed up biologics development. Embracing cutting-edge tools empowers scientists to maximize biology's potential, delivering efficient and impactful biotech solutions.In this episode of The Smart Biotech Scientist Podcast, host David Brühlmann explores these transformative methodologies with Jeremy Agresti, CTO and founder of Triplebar.Jeremy highlights the future of bioprocessing at the intersection of high-throughput screening, miniaturization, and AI. With tools that enhance predictability, scalability, and efficiency, Triplebar is set to transform biotechnology. By reimagining traditional methods, improving inputs, and leveraging modern technology, companies like Triplebar are driving a new era in bioprocessing, offering innovative solutions to complex biological challenges.Key Takeaways:Jeremy challenges the traditional view of scale-up issues, emphasizing that many problems can be solved at a smaller scale with better engineered strains and cell lines.By creating tiny bioreactors of droplets, Triplebar is able to perform high throughput screening, testing millions of mutations quickly and efficiently, and providing robust solutions for complex biological functions.The integration of massive data sets with AI allows for improved enzyme and protein design, unlocking the potential to innovate even when foundational understanding is limited.Ready to dive deeper? Join the journey of transforming bioprocess development with smart insights and pioneering spirit. Catch up with Jeremy's full story via the latest episode of the Smart Biotech Scientist podcast.Connect with Jeremy Agresti:LinkedIn: www.linkedin.com/in/jeremy-agresti-88546850/Triplebar: www.triplebar.comNext Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Learn more at https://bruehlmann-consulting.com

Send us a textIs your bioprocess facility wasting precious time and resources on traditional weighing system calibrations? In this eye-opening episode, Anders Tvegaard, COO of Eilersen Electric, reveals how digital load cell innovation is revolutionizing bioprocess monitoring and validation.Discover why weighing systems aren't the commodity technology you might think they are, and how choosing the right solution can dramatically reduce deviations and maintenance costs. Anders shares groundbreaking insights about Eilersen's water-free calibration system, which has helped customers save over a million liters of water and 700 man-hours in tank calibration time.Key takeaways:Why a single weighing system deviation can cost facilities $10,000+ in quality management aloneHow new digital load cell technology enables continuous monitoring during mobile vessel transportThe game-changing advantages of water-free calibration for single-use systemsReady to transform your bioprocess monitoring strategy? Listen now to learn how modern weighing technology can protect your products and streamline your operations.Connect with Anders Tvegaard:LinkedIn: https://www.linkedin.com/in/anders-tvegaard-3305a1Eilerson: https://eilersen.comNext Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Learn more at https://bruehlmann-consulting.com

Send us a textWhat do furniture manufacturing and bioprocess weighing have in common? In this fascinating episode, Anders Tvegaard, COO of Eilersen Electric Digital Systems shares the remarkable story of how his company evolved from solving a furniture maker's wood humidity measurement problems to revolutionizing pharmaceutical manufacturing.Fifty years ago, a simple request to build a more robust scale for weighing wood in sofa production led to the development of groundbreaking contactless load cell technology.Key takeaways for bioprocess professionals:Discover how a furniture problem sparked innovation in bioprocess weighing technologyLearn why traditional strain gauge technology may be compromising your mobile vessel operationsUnderstand how contactless load cells eliminate costly calibration deviations and production stopsFrom humble beginnings in a Danish basement to transforming modern bioprocessing, this episode reveals how cross-industry innovation is reshaping pharmaceutical manufacturing. Whether you're managing mixing tanks, mobile vessels, or single-use systems, you'll gain valuable insights into improving your bioprocess reliability.Ready to discover how furniture-inspired technology is solving today's bioprocessing challenges? Tune in now.Connect with Anders Tvegaard:LinkedIn: https://www.linkedin.com/in/anders-tvegaard-3305a1Eilerson: https://eilersen.comNext Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Learn more at https://bruehlmann-consulting.com

Send us a textCan artificial intelligence revolutionize drug development and reduce the staggering 90% failure rate in clinical trials? In this insightful episode, Lars Brandén, Director of Biology at Kolibri, shares his vision for the future of personalized medicine.Drawing from his extensive experience bridging academia and industry, Lars explores how AI models could transform our understanding of human disease by simulating body-wide cell signaling. He reveals an innovative approach to drug delivery using receptor ligand combinations that could dramatically reduce side effects and improve treatment efficacy.Key takeaways:Learn why maintaining "youthful naivety" in biotech innovation can lead to breakthroughs others deemed impossibleDiscover how combining AI with deep biological understanding could reduce clinical trial failure rates from 90% to potentially 15%Understand why interdisciplinary collaboration between biologists, software engineers, and other experts is crucial for advancing personalized medicineReady to dive deeper into the future of biotech innovation? Listen now to unlock Lars Brandén's insights on scaling therapies, navigating cross-functional teams, and maintaining scientific creativity in the face of challenges.Connect with Lars Brandén:LinkedIn: https://www.linkedin.com/in/larsbrandenNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a textIn this episode, we explore the delicate dance between artificial intelligence and biological research with Lars Brandén, Director of Biology at Kolibri. From his early fascination with gene therapy to pioneering high-throughput screening centers at prestigious institutions, Lars shares invaluable insights on bridging the gap between academic innovation and industrial application.What sets this conversation apart is Lars' compelling perspective on why the popular "agile development" model doesn't always translate smoothly to bioprocess development – and why that matters for the future of drug development. His journey from the Karolinska Institute to leading cutting-edge biological research offers a unique lens on the evolution of biotech.Key takeaways for listeners:Learn why scientists must develop broader cross-disciplinary knowledge to effectively leverage AI tools in researchDiscover how AI could dramatically reduce drug development timelines and costs within the next five yearsUnderstand the potential for AI to democratize access to cell and gene therapies through optimized production methodsJoin us for this fascinating exploration of how domain expertise and artificial intelligence can work in harmony to accelerate breakthrough therapies. Whether you're a biotech professional or simply curious about the future of medicine, this episode offers valuable insights into the transformation of drug development in the AI era.Listen now to discover how the intersection of human expertise and artificial intelligence is reshaping the future of personalized medicine.Connect with Lars Brandén:LinkedIn: https://www.linkedin.com/in/larsbrandenNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

Send us a textCould Earth's gentle movements hold the key to scaling up cell therapy production? In this fascinating episode, cellular biologist and entrepreneur Olivier Detournay (CSO of Cellura) reveals how his groundbreaking bioreactor design, inspired by geophysics, is transforming difficult cell culture processes.By mimicking natural planetary motions, his team at Celura has developed a low-shear stress bioreactor that elegantly solves common scale-up challenges.Key takeaways for biotech professionals:Discover how reducing rotational speed in larger volumes (from 70 RPM at 150ml to just 4 RPM at 200L) enables seamless scale-upLearn why simplifying bioreactor design leads to better control over shear stress and mixing qualityExplore how nature-inspired solutions could make cell therapy manufacturing more accessible and cost-effectiveWhether you're working in process development or manufacturing, this episode offers invaluable insights into the future of bioprocessing.Listen now to uncover how looking to nature might help solve your toughest scale-up challenges.Connect with Olivier Detournay:LinkedIn: https://www.linkedin.com/in/olivier-detournay-5b157417Cellura: https://cellura.ioNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO/CSO services. Curious? Learn more at https://bruehlmann-consulting.com

Send us a textWhat if the secret to growing sensitive cells lies in mimicking Earth's own movement? In this fascinating episode, cellular biologist Olivier Detournay, CSO of Cellura, reveals how studying planetary motion led to a groundbreaking bioreactor design that could transform cell therapy manufacturing.Drawing inspiration from geophysics research on magma flows, Olivier and his colleagues developed a revolutionary impeller-free bioreactor that creates gentle, uniform mixing through precise rotation and tilt angles.Key takeaways for bioprocess scientists:Learn how natural planetary movements can inspire gentler cell cultivation methodsDiscover an innovative approach to scaling up sensitive cell production without shear stressUnderstand why traditional impeller-based systems may limit the future of bioprocessingWhether you're working with stem cells, immunotherapy, or cultivated meat, this episode offers fresh perspectives on overcoming bioprocessing challenges. Join us to explore how nature-inspired solutions could make life-saving cell therapies more accessible.Connect with Olivier Detournay:LinkedIn: https://www.linkedin.com/in/olivier-detournay-5b157417Cellura: https://cellura.ioNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO/CSO services. Curious? Learn more at https://bruehlmann-consulting.com

Send us a textIn this captivating episode, we dive deep into the groundbreaking intersection of artificial intelligence and enzyme engineering with David Schönauer, founder and CEO of Aminoverse.From university lab benches to pioneering AI-driven enzyme discovery, David shares how his startup is transforming the biotech landscape by making enzyme development faster, more predictable, and increasingly efficient.Highlights:Discover how AI is revolutionizing enzyme prediction and design, potentially reducing development time from years to weeksLearn why high-quality wet lab data remains crucial for AI success in biotech, and how Aminoverse's unique approach combines both worldsGain insights into building a profitable biotech startup without massive venture capital funding, proving that sustainable growth is possible in deep techDavid's journey from academic researcher to biotech entrepreneur offers invaluable lessons for scientists considering the entrepreneurial path. His practical approach to combining cutting-edge AI with traditional wet lab techniques demonstrates how modern biotechnology can solve real-world problems while maintaining scientific rigor.Ready to explore the future of biotech? Listen now to learn how AI is transforming enzyme engineering and what it means for the future of sustainable technology, pharmaceuticals, and more.Connect with David Schönauer:LinkedIn: https://www.linkedin.com/in/david-schönauerAminoverse: https://www.aminoverse.comNext Steps:Wondering how to develop biologics with clarity and precision? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentReady to revolutionize your biologics development? Our Fractional CTO services help you develop better, faster, and more cost-effectively. Leverage your full potential today — book a free consultation at https://bruehlmann-consulting.com and let's accelerate your success!

Send us a textEver wondered how scientists find the perfect enzyme among billions of possibilities? In this fascinating episode of the Smart Biotech Scientist podcast, host David Brühlmann sits down with David Schönauer, CEO of Aminoverse, who's revolutionizing enzyme engineering through artificial intelligence.As a biotech entrepreneur who transformed his academic passion into a groundbreaking startup, Schönauer shares how his company is solving one of biotechnology's biggest challenges: efficiently identifying the right enzyme for specific applications, from pharmaceutical manufacturing to sustainable consumer products.Key Takeaways:Discover how Aminoverse's innovative platform navigates through more than one billion enzyme sequences to identify the most promising candidatesLearn why the perfect balance between AI-powered screening and traditional lab testing is crucial for successful enzyme engineeringUnderstand how engineered enzymes are transforming industries, from mRNA vaccine production to eco-friendly laundry detergentsWhether you're a biotech professional or simply curious about the intersection of AI and biotechnology, this episode reveals how cutting-edge technology is accelerating the discovery of nature's molecular workers.Ready to explore the future of enzyme engineering? Tune in now to hear how AI is transforming biotech innovation, one enzyme at a time.Connect with David Schönauer:LinkedIn: https://www.linkedin.com/in/david-schönauerAminoverse: https://www.aminoverse.comNext Steps:Wondering how to develop biologics with clarity and precision? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentReady to revolutionize your biologics development? Our Fractional CTO services help you develop better, faster, and more cost-effectively. Leverage your full potential today — book a free consultation at https://bruehlmann-consulting.com and let's accelerate your success!

Send us a textIn this insightful episode, Technical Development Leader at Flagship Pioneering Oliver Kraemer reveals why developing Advanced Therapy Medicinal Products (ATMPs) require a fundamental shift in thinking from traditional biologics development.Drawing from his extensive experience across Boehringer Ingelheim, Sanofi, and BMS, Kraemer challenges conventional wisdom about process development timing and demonstrates why early integration of process considerations is crucial for ATMP success.You will learn:Rethink Development Timing: Learn why incorporating process development earlier in ATMP programs dramatically reduces failure rates and prevents costly repetitionMaster Complexity: Understand the unique challenges of cell therapy development, including biological fitness and the critical interplay between cell lines, media, and processesNavigate Cost Implications: Discover strategies for managing the unexpectedly high development costs of ATMPs and making informed early decisions that impact commercial successReady to transform your approach to ATMP development? Join us for this must-listen episode as we demystify the path from bench to bedside in cell and gene therapy.Connect with Oliver Kraemer:LinkedIn: https://www.linkedin.com/in/oliver-kraemerNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop cell and gene therapies better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Learn more at https://bruehlmann-consulting.com

Send us a textIn this eye-opening episode, we explore the intricate landscape of Advanced Therapy Medicinal Products (ATMPs) with Oliver Kraemer, a technical development leader at Flagship Pioneering.Drawing from his extensive experience at industry giants like BMS, Sanofi, and Boehringer Ingelheim, Oliver challenges conventional wisdom about automation in cell and gene therapy while illuminating the crucial differences between biologics and ATMPs.Key Takeaways for Biotech Scientists:Discover why automation isn't the ultimate solution for advancing CGT development right now, and what this means for your process development strategyLearn how ATMP development requires a fundamental rethinking of the traditional research-to-development pipelineUnderstand the critical early-stage decisions in cell therapy development that can make or break your project timelineJoin us as Oliver shares invaluable insights from his journey from traditional biologics to cutting-edge cell therapies, including both iPSC-derived and donor-derived approaches. Whether you're a bioprocess developer, cell therapy researcher, or biotech professional, this episode offers practical wisdom for navigating the complex landscape of ATMP development.Ready to transform your understanding of cell therapy development? Listen now to gain insights that could save you months or even years in your development timeline.Connect with Oliver Kraemer:LinkedIn: https://www.linkedin.com/in/oliver-kraemerNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop cell and gene therapies better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Learn more at https://bruehlmann-consulting.com

Send us a textWant to peek behind the curtain of a leading Contract Development and Manufacturing Organization (CDMO)? In this inspiring episode, KBI Biopharma's Chief Scientific Officer Sigma Mostafa reveals the intricate world of bioprocess development and manufacturing.Sigma shares game-changing insights into accelerating biologics development without compromising quality. She also unveils how KBI is leveraging AI and machine learning to revolutionize everything from protein sequence analysis to formulation development.Key Takeaways:Learn how to master the art of seamless tech transferDiscover how to slash development timelines using innovative cell line technology and parallel processingLearn how AI and machine learning are transforming CDMO operations, from predicting developability challenges to automating lab processesReady to transform your bioprocess development journey? Tune in to hear Sigma's vision for the future of CDMOs and get actionable insights for your next project.Connect with Sigma Mostafa:Linkedin: https://www.linkedin.com/in/sigma-mostafa-79180817KBI: https://www.kbibiopharma.comNext Steps:Wondering how to fast-track bioprocess CMC development? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

Send us a textIn this insightful episode, we're joined by Sigma Mostafa, Chief Scientific Officer at KBI Biopharma, who shares crucial insights on selecting the right CDMO partner for biotech development.Sigma brings a unique blend of scientific rigor and practical experience to the discussion, having worked on both sides of the CDMO relationship.Key Takeaways:Why harvest steps deserve more attention in bioprocess developmentThe truth about one-stop-shop CDMOs versus specialized partnersCritical factors in cell line and media selection that impact long-term successSigma emphasizes that successful CDMO partnerships hinge on transparent communication and cultural alignment, not just technical capabilities. She reveals that while one-stop shops seem convenient, partnering with specialized CDMOs who excel in specific areas often yields better results - as long as there's strong project coordination.Whether you're a startup navigating your first CDMO relationship or an established biotech company looking to optimize your partnerships, this episode provides actionable insights for making informed decisions that will impact your project's success for years to come.Listen now to transform your approach to CDMO selection and avoid costly pitfalls in your bioprocess development journey.Connect with Sigma Mostafa:Linkedin: https://www.linkedin.com/in/sigma-mostafa-79180817KBI: https://www.kbibiopharma.comNext Steps:Wondering how to fast-track bioprocess CMC development? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

Send us a textStruggling to unravel the complexities of your bioprocess? Prepare for a paradigm shift as we dive into the world of Process Analytical Technology (PAT) with Katharina Dahlmann who is Application and PAT Expert at Hamilton.This eye-opening episode dissects how PAT is redefining biologics manufacturing, balancing its immense potential against real-world implementation hurdles. Katharina navigates us through the intricate journey of scaling up, from micro-bioreactors to large-scale bioreactors, unveiling the hidden gems of early PAT adoption. Whether you're a startup scientist or a seasoned biotech veteran, this episode is packed with insights to elevate your bioprocessing game.Tune in to uncover:Strategies for overcoming PAT implementation challengesExpert tips on scaling up your processes with confidenceA fresh perspective on cross-disciplinary collaboration in biotechDon't let bioprocess complexity hold you back – listen now and harness the power of PAT to decode your processes like never before!Connect with Katharina Dahlmann:LinkedIn: https://www.linkedin.com/in/dr-katharina-dahlmann-616790180Hamilton: https://www.hamiltoncompany.comNext Steps:Wondering how to develop biologics with clarity and precision? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com