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

• 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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• 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development - Part 2

  Your process works perfectly at two-liter bench scale. Then you hit fifty liters and titer drops 20%. By two hundred liters, aggregation appears and charge variants shift. Your management team asks: "How long to fix this?" The honest answer? Three to twelve month, because you're flying blind.In Part 2 of this Quality by Design Master Class, David Brühlmann reveals why scale-up chaos isn't inevitable. It's a solvable engineering problem. Drawing on experience leading bioprocess innovation at Merck and guiding biotech companies through CMC development, David delivers the process control framework that transforms reactive troubleshooting into predictive manufacturing.The core truth: eighty percent of quality problems stem from twenty percent of your process variables. David shows how to identify Critical Process Parameters, implement intelligent control strategies, and leverage hybrid modeling that reduces experiments by 60-80%. With case studies from Genentech and Amgen, you'll gain the blueprint that turns QbD requirements into competitive advantage.Part 1 taught you what to build and measure. Part 2 shows you how to control your process to consistently deliver commercial-scale quality.Topics Discussed:The common pitfalls of scaling up manufacturing from bench to production, and why process control must go beyond end-product testing (02:10)Overview of the QbD framework: Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), and the focus of this episode - Control Strategies for manufacturing (05:00)Identifying and monitoring Critical Process Parameters (CPPs) and their impact on quality, with real-world examples from Genentech’s monoclonal antibody platform (08:20)Structure of an effective manufacturing control strategy: Input, process, and output controls - including practical details on real-time monitoring and release testing (11:00)The role of hybrid modeling and machine learning in accelerating process optimization, and how this approach can dramatically reduce the experimental burden (13:30)Real examples of improved outcomes and efficiency through model-based control strategies, and why training and process understanding are essential for team success (16:10)A quick, actionable exercise biotech teams can use to map process risks and identify critical control points (16:55)Whether you’re part of a start-up or a large biotech firm, this episode offers clear, strategic steps for implementing QbD and improving process reliability. Don’t forget to listen to Part 1 for more on QTPP and CQA, and visit www.bruehlmann-consulting.com for additional resources.Next step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callPreparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105🧬 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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• 199: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development - Part 1

  Over 40% of biotherapeutic failures during clinical development stem from stability problems—and most trace back to protein aggregation that could have been prevented. In this episode of the Smart Biotech Scientist Podcast, David Brühlmann exposes the hidden manufacturing crisis that derails promising biologics programs and delivers the systematic Quality by Design framework that elite biotech companies use to build quality into every process step.David brings two decades of bioprocess expertise from his time leading technology innovation at Merck and now guiding emerging biotech companies through CMC development as Managing Director of Brühlmann Consulting. Drawing on FDA and EMA regulatory guidance as well as landmark industry case studies he transforms complex QbD principles into an actionable roadmap for IND submission.This isn't theoretical regulatory compliance. It's competitive survival. Companies implementing these QbD foundations achieve predictable manufacturing scale-up, accelerated regulatory approval, and significant cost advantages. If your team is navigating CMC development for the first time or struggling with scale-up challenges, this episode provides the blueprint to transform process uncertainty into manufacturing confidence.What You’ll Learn in This Episode:The high clinical failure rate for biologics due to protein aggregation and stability problems, and one company’s costly lesson in the scale-up phase. (00:00)An introduction to Quality by Design (QbD)—how it differs from traditional development and why “the process is the product” in biologics. (03:09)The three foundational pillars of QbD, with today’s focus on product understanding and quality requirements. (05:46)Constructing your Quality Target Product Profile (QTPP): what to include and why starting with the patient is key. (07:05)A real-world QTPP example—the AMAP case study—and how it shaped formulation, packaging, and critical quality standards. (09:45)Defining and prioritizing Critical Quality Attributes (CQAs): measuring what truly matters for safety and efficacy. (11:50)Lessons from Roche/Genentech’s QbD journey: regulatory insights and the business value of robust CQA identification. (15:55)The “CQA Reality Check” exercise: a step-by-step method to focus your team on attributes that impact patients. (21:05)How early, candid dialogue with regulators and using management tools like the Notion CMC Dashboard can streamline the development roadmap and reassure investors. (23:30)Ready to flip the odds in your favor and make QbD your competitive edge? Stream this episode to catch actionable strategies and real-world cautionary tales that could change your CMC development playbook for good.Next step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callPreparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105🧬 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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• 198: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda Hoertz - Part 2

  What happens when the most complex molecules in biotech meet the organizational challenge of managing 300+ analytical scientists? The answer lies not just in the science, but in building systems that turn technical complexity into reliable delivery.In Part 2 of our deep dive with Amanda Hoertz, VP of Analytical and Formulation Sciences at KBI Biopharma, we shift focus from the molecular intricacies of ADCs to the operational mastery required to scale analytical development across multiple sites. Amanda reveals how her team achieves consistency across hundreds of scientists while maintaining the agility to pivot priorities in real time when critical programs need emergency support.This isn't just about managing people; it's about architecting systems that preserve institutional knowledge, accelerate method transfer, and deliver results when regulatory deadlines loom.What you'll discover:Seamless Project Handoffs Without Knowledge Loss: How KBI's stable team assignments eliminate the costly learning curves that plague most CDMO relationships, ensuring your molecule expertise stays with your program from development through commercial manufacturing.Organizational Scale Without Operational Chaos: The decision tree and layered reporting structure that allows 200+ analysts at a single site to function as a coordinated force, capable of rapid reprioritization and flood-level resource deployment when programs reach critical status.Digital Transformation That Actually Works: Beyond the automation buzzwords, Amanda walks through the practical realities of LIMS/ELN implementation, audit-compliant systems, and machine learning databases that transform raw data into defensible, actionable insights for complex biologics.Whether you're evaluating how analytical capabilities scale with program complexity, or seeking practical insights into leading technical teams through digital transformation, this episode delivers the operational intelligence that separates successful ADC programs from expensive failures.Connect with Amanda Hoertz:LinkedIn: www.linkedin.com/in/amanda-hoertz-3aba605KBI Biopharma: www.kbibiopharma.comKBI Portal: www.standalone.kbi.bioNext step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call🧬 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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