Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

• 205: Process Economics Decoded: How to Model Biomanufacturing Costs From Clinical to Commercial Scale with Niklas Jungnelius - Part 1

  Your Manufacturing Decisions Are Costing You More Than You ThinkEvery bioreactor decision. Every scale-up choice. Every facility investment. They're all silently writing checks your process might not be able to cash.The difference between a profitable biologics program and one that bleeds capital? Process economic modeling, the analytical framework that reveals exactly where your money goes and why.In this episode of the Smart Biotech Scientist Podcast, David Brühlmann talks with Niklas Jungnelius, Process Modeling Leader at Cytiva, who has spent 25+ years decoding the economics of biologics manufacturing for biotech companies navigating billion-dollar decisions.Niklas reveals the hidden cost drivers most teams miss, the surprising economics behind fed-batch vs. continuous processing, and why your facility choice at intermediate scale could make or break your business case.Episode Highlights:What process economic modeling is and how it differs from mechanistic modeling (06:40)Main cost drivers in biologics and biosimilars manufacturing, and their direct and indirect impacts on patient pricing (09:21)The role of manufacturing scale and productivity in driving down costs, and how facility type (stainless steel vs single-use) affects labor, flexibility, and investment (11:51)Trade-offs between single-use and stainless steel facilities at intermediate production scales (15:07)Key differences in cost and efficiency between fed-batch and fully continuous manufacturing, including productivity limitations and capital/expenditure implications (16:20)The impact of resin lifetime and under-utilization on clinical manufacturing costs (19:51)Hidden or less quantifiable costs such as facility flexibility, excess capacity, safety margins, and the importance of realistic assumptions in economic modeling (20:20)This is a grounded discussion with practical takeaways for biotech scientists seeking clarity in the complex terrain of process economics. Part two of this conversation will focus on sustainability modeling and the latest technologies reshaping bioprocessing economics.Ready to see how process modeling could transform your approach and protect your bottom line? Listen to the episode and rethink your next investment.Connect with Niklas Jungnelius:LinkedIn: www.linkedin.com/in/niklas-jungneliusCytiva website: www.cytivalifesciences.com/en/usNext step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

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• 204: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 2

  Cell and gene therapies are transforming modern medicine, but their path to market is fast and complex. They often jump from small trials to global launch at record speed, putting pressure on analytics, supply chains, and partnerships. Success depends on making smart choices about what to build in-house and what to entrust to expert partners.Daniel Galbraith knows these challenges intimately. With decades of hands-on experience and as Chief Scientific Officer at Solvias, Daniel has witnessed firsthand the seismic shifts in analytical development for advanced therapies. He’s been on every side of the table: troubleshooting manufacturing snags, scaling up from a single batch to hundreds per month, and guiding companies as they choose between in-house development and relying on a CRO’s muscle.In this episode:How evolving cell and gene therapy timelines are driving the need for true CRO-drug developer partnerships (00:00)The unique challenges of scaling CMC analytics from early trials to global commercialization (02:51)Key pitfalls to avoid when outsourcing to CROs—especially around communication, scheduling, and troubleshooting (06:26)Deciding whether to build capabilities in-house or outsource to a CRO, and how to find the right balance for your team (08:41)The critical importance of strong project management for juggling relationships between developer, CRO, and CDMO (09:51)Daniel's perspective on the future of combination therapies and what the analytical landscape will demand of CROs (13:33)Practical advice for building transparent, open CRO partnerships that support your goals (15:21)Facing scale-up challenges or a first CGT launch? This conversation shares practical strategies to advance therapies efficiently.Tune in for actionable insights on CMC, outsourcing, and analytical development.Connect with Daniel Galbraith:LinkedIn: www.linkedin.com/in/daniel-galbraith-26a6138Solvias website: www.solvias.comEmail: [email protected] step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callPreparing for your IND? Grab our Startup Founder CMC Dashboard in Notion to help you track tasks, timelines, and risks in one place at https://stan.store/SmartBiotech/p/discovertoind-cmc-dashboard-for-startup-founders🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

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• 203: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 1

  Finding an analytical CRO that's truly invested in your success, not just processing samples, makes all the difference in CMC development. In this episode, host David Brühlmann talks with Daniel Galbraith, Chief Scientific Officer at Solvias, about the essential questions and mindset that lead to breakthrough CRO partnerships.With nearly three decades in analytical development, spanning monoclonal antibodies, biosimilars, and cell and gene therapies, Daniel reveals what separates CROs who become true partners from those who just run methods. His insights can save your program months of delays and costly missteps.Key Topics Discussed:Why cell and gene therapies face unique challenges compared to the progression seen with monoclonal antibodies (03:04)Daniel’s career path: from entering biotech in 1996 to CSO at Solvias, and the rapid evolution of the industry (05:00)The analytical hurdles in characterizing cell-based products and how their inherent variability impacts development (09:46)Approaches to analytical method requirements for autologous cell therapies, and how data is gathered iteratively in these cases (13:02)The biggest obstacles to scaling up cell and gene therapies, and why innovative cell manipulation technologies are needed (16:06)Current trends in therapeutic modalities: why antibody-drug conjugates stand out, and whether mRNA therapies are losing momentum (18:37)Practical advice on choosing an analytical CRO as a strategic partner - what to look for, what questions to ask, and why enthusiasm and standardization matter (21:55)Wondering how to streamline your own analytical strategy, or navigate the parallel universe of cell and gene therapy development? Dig into this episode for Daniel’s insider perspective. Then consider how the right analytical partnership could accelerate your path to clinic.Connect with Daniel Galbraith:LinkedIn: www.linkedin.com/in/daniel-galbraith-26a6138Solvias website: www.solvias.comEmail: [email protected] step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callPreparing for your IND? Grab our Startup Founder CMC Dashboard in Notion to help you track tasks, timelines, and risks in one place at https://stan.store/SmartBiotech/p/discovertoind-cmc-dashboard-for-startup-founders🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

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• 202: Fighting Antimicrobial Resistance: How AI Cuts Phage Therapy Access from 6 Months to 5 Days with José Bila - Part 2

  What if the answer to battling antibiotic-resistant infections isn’t a new antibiotic, but harnessing viruses that have been quietly dominating bacterial populations?Bacteriophages, viruses that target and kill bacteria, have been saving lives for a century, but their true potential is only now being unlocked by modern machine learning. The race isn’t just about discovering effective phages; it’s about deploying the right therapy, personalized to the patient, before time runs out.On this episode, David Brühlmann welcomes José Luis Bila, Co-Founder and CEO of Precise Health. Driven by personal tragedy and an engineer’s mindset, José is shaping a future where AI-powered phage therapy isn’t a niche solution, but a scalable, accessible weapon against the superbugs that evade antibiotics. From building bioreactor capacity to navigating regulatory gray zones, José brings a rare blend of technical vision and practical urgency to a problem that affects families and health systems worldwide.Key topics discussed:The challenge of evolving bacteria and phages, and the question of whether it’s possible to keep up with nature’s pace through engineering new phages in silico (00:00)Overview of bacteriophage production: complexity, types of bioreactors used, and comparison with chemical synthesis (02:54)Bioproduction logistics: using CDMOs vs. in-house hospital production and the real-world timescales for manufacturing (02:32)Barriers for smaller or less funded hospitals, especially in low- and middle-income countries, with thoughts on hospital infrastructure differences worldwide (04:41)Creative solutions for cost-effective phage production in remote and underserved regions, such as the potential for single-use or mobile bioreactors (06:01)Why downstream processing and ensuring product purity is a bottleneck; the need for miniaturization and economic scalability (06:40)Parallels and differences in downstream processing between bacteriophages and viral vectors (09:15)The vital role of stability and shelf life for phage therapy logistics and economic viability (09:15)Regulatory pathways for phage therapy in Europe and beyond, including magistral preparations, ethical approvals, and adapting to digital tools for selection (12:39)The future vision: routine clinic entry through matching existing phage libraries, with longer-term goals of engineering bespoke phages via AI when necessary (15:52)José’s perspective on building global infrastructure and making phage therapy cost-effective and universally accessible (18:08)José Bila’s message: solutions to antimicrobial resistance are within reach. The biotech community must build accessible infrastructure, using AI and innovative systems to ensure phage therapy benefits reach every patient, everywhere.Connect with José Luis Bila:LinkedIn: www.linkedin.com/in/josé-luis-bila-phd-3b08a5a7Precise Health SA: www.precisehealth.ioInterested in how scientists are fighting superbugs? Learn how phage therapy and smart bioprocess design are helping outmaneuver drug-resistant pathogens. Check out this interview with one of our previous guests!Episodes 187-188: From Biology Is Messy to Designable: The Smart Bioprocessing Transformation with Carmen Jungo RhêmeNext step:Book a 20-minute call to help yo🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

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• 201: Fighting Antimicrobial Resistance: How AI Cuts Phage Therapy Access from 6 Months to 5 Days with José Bila - Part 1

  Antibiotic resistance isn’t just a looming problem. It’s a global crisis. Every year, more than one million people die directly from resistant infections, and another 5 million die indirectly. Routine infections are becoming life-threatening, and healthcare systems worldwide are under pressure.Despite decades of warnings, pharmaceutical solutions are falling behind, while “superbugs” continue to outpace new drug development. If trends continue, by 2050, antibiotic resistance could claim 10 million lives annually and cost the world $1 trillion.Meet José Luis Bila, a chemist-turned-biotech-founder, who transformed personal tragedy into a mission to disrupt this deadly status quo. After losing both parents to antibiotic-resistant infections, José dedicated his career to the search for targeted, effective alternatives. Now, as Co-Founder and CEO of Precise Health SA, he’s building AI-powered bacteriophage therapy platforms that promise to revolutionize personalized infection treatments and outmaneuver today’s most stubborn bacteria.Why tune into this episode? Here are three standouts from José’s story and his technical playbook:José's personal story: Losing both parents to antibiotic resistance and its impact on his career path. (00:00)Scope of the antibiotic resistance crisis: Global deaths, indirect impacts, and economic cost projections. (06:29)Why big pharma is pulling out of antibiotic development and why innovation may come from smaller startups. (07:29)Why antibiotic resistance persists: Static nature of antibiotics versus adaptable bacteria, and misuse of antibiotics. (09:45)Introduction to bacteriophage therapy and its specificity challenges. (11:46)The current slow, manual process for matching phages to infections and its limitations in urgent clinical settings. (13:08)How machine learning is being used at Precise Health to rapidly identify and source the right phages using genetic information. (16:58)The potential to reduce phage matching and delivery time from months to just days, and how smart batching and regional surveillance improve economics. (17:23)José Luis Bila’s journey shows the power of science driven by purpose. Through persistence, he’s pioneering AI-driven phage therapy - offering precision, hope, and a potential lifeline in the fight against antibiotic-resistant infections.Connect with José Luis Bila:LinkedIn: www.linkedin.com/in/josé-luis-bila-phd-3b08a5a7Precise Health SA: www.precisehealth.ioInterested in how scientists are fighting superbugs? Learn how phage therapy and smart bioprocess design are helping outmaneuver drug-resistant pathogens. Check out this interview with one of our previous guests!Episodes 187-188: From Biology Is Messy to Designable: The Smart Bioprocessing Transformation with Carmen Jungo RhêmeNext step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

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