Shows
Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 2What happens between scientific discovery and clinical trials? For too many drug candidates, the answer is “failure”—not because the idea lacked merit, but because the critical handoff between discovery and IND-enabling studies gets overlooked, rushed, or under-resourced.This episode features Milan Tomic, whose journey stretches from nucleic acid chemistry to leading GMP manufacturing and biodefense initiatives with hundreds of millions in US government support. Milan’s focus lies in streamlining drug development, from rapid molecule design to building manufacturing infrastructure, all grounded in holistic, systems-level thinking.Topics discussed:Why so many promising programs fail bet...
2026-06-0424 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1The gap between a “drug” and a true “product” is where many therapies fail.Milan Tomic, biotech veteran, GMP manufacturing expert, and founder of Albrem, has spent 30 years turning promising science into scalable, executable products that can actually reach patients. His experience spans everything from antibody development to building large-scale GMP facilities. Today, he helps biotech teams align scientific innovation with the operational and regulatory realities needed for successful commercialization.Topics discussed:Milan’s path from curiosity-driven research in molecular biology to biotech industry leadership (05:24)The importance of integrating work-life factors into career decisions, and balanc...
2026-06-0223 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders252: How to Use Media Supplements to Tailor Biosimilar Glycan Quality to Your Reference Product in Two RoundsAre you still using one-factor-at-a-time experiments for biosimilar development, losing months, missing interactions, and risking costly dead-ends?In this episode, David Brühlmann, host of the Smart Biotech Scientist Podcast, reveals how traditional "one factor at a time" screening in biosimilar development can take over 12 months, while the parallel group design massively accelerates discovery by grouping up to five factors per experiment and applying a multivariate analysis pipeline.Topics discussed:The limitations of traditional and large DoE designs and the advantages of parallel group design (00:08)Best practices for grouping compounds by biological mechanism with f...
2026-05-1418 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders251: Why a Single Large DoE Fails Biosimilar Glycan Optimization — And the Parallel Screening Method That Actually WorksAre you stuck screening endless compounds in biosimilar development and still not hitting your quality targets? Efficient compound screening is one of the toughest bottlenecks in biopharma, with outdated methods slowing progress and risking critical quality attributes in monoclonal antibody development.David Brühlmann breaks down a practical, parallel framework for rapid compound screening that addresses interaction effects, masking, and data quality. Methods proven in challenging biosimilar development programs.Topics discussed:The historical bottleneck of one-at-a-time screening in drug discovery and the impact of high throughput methods (01:04)Problems with both one-factor-at-a-time and large design o...
2026-05-1218 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders248: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 2Getting an NDA signed shouldn't take weeks. If your CRO needs more than 48 hours to start the paperwork, your project timeline is already moving in the wrong direction.Ron Najafi knows what rigorous analytical work actually looks like under pressure. As founder and CEO of Emery Pharma, he led the investigation that identified NDMA as a degradation product of ranitidine — findings the FDA formally validated and that reshaped how the industry approaches nitrosamine risk assessment. In Part 2, he moves from that scientific foundation into the operational questions that determine whether a CRO partnership accelerates your program or qu...
2026-04-3019 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders247: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 1When drug safety fails, patients and entire markets pay the price. Understanding your CMC isn't just compliance — it's the line between therapeutic promise and product recall.Ron Najafi has lived that reality firsthand. As founder of NovaBay Pharmaceuticals and Emery Pharma, he spent decades building companies at the intersection of analytical chemistry and drug development. His investigation into nitrosamine contamination in ranitidine — which led the FDA to formally validate Emery Pharma's findings — remains one of the most consequential episodes in recent pharmaceutical quality history.In Part 1, Ron traces the scientific and entrepreneurial path that led him th...
2026-04-2832 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders246: Why Your Shake Flask Culture Doesn't Scale: OTR, Shaking Diameter, and How to Fix It with Tibor Anderlei - Part 2Shear sensitivity is the silent challenge behind many advanced biomanufacturing modalities. Orbital-shaken bioreactors—often underestimated—may be a key enabler your CMC development is missing.Tibor Anderlei, CSO at Kühner Shaker, joined David Brühlmann on the Smart Biotech Scientist Podcast to unpack the hidden physics behind bioprocess reproducibility and next-generation shaking technology. He has seen firsthand how overlooking fundamental parameters can derail scale-up and delay development timelines. In his role, Tibor is responsible for the customer interface—spanning sales, service, support, GMP topics, troubleshooting, marketing, and applied technology—with a focus on orbital shaking technology and small...
2026-04-2322 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders244: Prevent the Delays That Derail Biologics Tech Transfer: 12-Week Protocol for CMCWhen a single mismanaged tech transfer threatens an entire development program, pressure on CMC leaders and bioprocess teams is intense. The truth? Tech transfers aren’t a black box. They’re complex, but solvable with the right mindset and playbook.In this episode, David Brühlmann explores the practical side of tech transfer and scale-up within the biotech industry. With more than 15 years of experience, he shares personal stories and industry-tested frameworks that help demystify the complexities of transferring technologies between sites or organizations. Instead of focusing solely on technical details, he emphasizes the crucial human and organ...
2026-04-1617 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders243: Turn Tech Transfer from a Gamble into a Managed Process: The 6-Pillar Biologics Scale-Up FrameworkWhat if the hidden cost of your bioprocess lies not in the technology, but in what you don’t document?Too often, biotech teams discover too late that their “proven” process is just an illusion, propped up by undocumented tricks and missing critical parameters. In this episode, David Brühlmann strips down the assumptions behind scale-up and tech transfer, exposing the silent risks that threaten CMC milestones and market launches alike. After 15 years guiding biotech projects from bench to clinic, he’s felt the pain of process gaps, regulatory curveballs, and million-dollar mistakes. Here, he turns that experienc...
2026-04-1414 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders242: DMSO in Cell Therapy: Why Viability Scores Hide the Real Toxicity with Steve Oh - Part 2What if the solution to cell therapy’s biggest cold-chain challenge comes from the biology of Arctic fish?This conversation features Steve Oh, a leader in advanced bioprocessing, whose career has placed him at the intersection of stem cell biology, process engineering, and clinical translation. Steve Oh joins David Brühlmann to share how XT Thrive®—a next-generation cryopreservation solution drawing from nature’s antifreeze proteins—lets cells survive, thrive, and simplify manufacturing from the bench to the clinic.Episode highlights:Biological insights from Arctic fish and their translation into synthetic peptide chemistry...
2026-04-0917 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders238: High-Throughput Microbial Screening: Avoiding Early Mistakes That Derail Scale-Up with Sebastian Blum - Part 2For many biotech innovators, high-throughput screening platforms promise faster discoveries and streamlined workflows. Yet beneath the surface, the reality is more demanding, requiring hands-on expertise, careful assay design, and a sharp understanding of microbial physiology to avoid mistakes that become expensive to fix downstream.David Brühlmann continues his conversation with Sebastian Blum, Market Development Manager in Europe at Beckman Coulter Life Sciences, who brings a practical, unvarnished perspective to high-throughput screening. Drawing on conversations with startups, pharma, and CDMOs, Sebastian digs into what separates "push-button" automation myths from hard-won bioprocess mastery. From evaluating technical fit to t...
2026-03-2613 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders237: High-Throughput Microbial Screening: Avoiding Early Mistakes That Derail Scale-Up with Sebastian Blum - Part 1Why do so many promising biotech ideas stall long before they reach the clinic or marketplace? For many, the answer lies hidden in the earliest phase of bioprocess development: upstream processing. It’s where strain selection, media optimization, and culture conditions set the stage for everything that follows. Yet, the smallest missteps here can snowball into expensive roadblocks downstream. This episode of Smart Biotech Scientist Podcast zeros in on why smart screening strategies and the right bioreactor choices early on are the difference between breakthrough and bottleneck.Joining host David Brühlmann is Sebastian Blum, a microbiologist wit...
2026-03-2419 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders234: Why Most Bioprocess Automation Projects Fail Before the Robot Is Even Ordered with Anthony Catacchio - Part 2Picture a new bioprocess automation project: ambitious, expensive, and packed with promise. But after months of development, your team discovers a flaw that could have been caught with a simple mockup and a few sticky notes on a whiteboard. This episode confronts the real cost of skipping discovery, premature automation, and the myth that faster engineering always means faster solutions.Anthony Catacchio, CEO of Product Insight, continues his conversation with David Brühlmann to untangle the realities of automation strategy in biotech. Drawing from years of building robotics for high-stakes labs, Anthony explores why "minimum testable product" c...
2026-03-1222 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders233: Why Most Bioprocess Automation Projects Fail Before the Robot Is Even Ordered with Anthony Catacchio - Part 1Many bioprocess automation projects fail, not because the technology is wrong, but because no one clearly defined the problem before buying the robot.In this episode, David Brühlmann sits down with Anthony Catacchio, CEO of Product Insight, to explore why rigorous system design and honest problem definition matter more than any individual technology, and how industrial robotics expertise translates directly into smarter lab automation.Highlights from the episode:Why biotech's "special case" mindset around automation is costing companies time and money — and what industrial robotics already has figured out (02:45).How Anthony's cross-industry career — from...
2026-03-1021 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann - Part 2How solid is your CMC foundation—and what happens if it cracks under pressure?David Brühlmann welcomes Henri Kornmann, former Head of Biologics Innovation Centre at Ferring Pharmaceuticals. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has moved repeatedly between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs.His “house building” approach demystifies CMC’s complexity, showing why early diligence paired with regulatory fluency and scientific insight pays dividends for years.Tune in to hear Henri’s p...
2026-03-0518 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders231: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann - Part 1Seventy percent of FDA Complete Response Letters have a CMC root cause. Most of those failures trace back to decisions made years earlier. Decisions that felt minor at the time and proved impossible to fix later.Henri Kornmann has spent two decades making those decisions the right way. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has crossed between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs. His conclusion: a CMC program is like building a house. Get the foundation...
2026-03-0319 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders228: Media-Based Glycan Engineering for Biosimilars: Your Rapid Implementation GuideHow early in process development should you address glycosylation? This episode presents the case for co-optimizing glycan profiles with productivity from initial process characterization. Deferring glycosylation characterization until after titer targets are met introduces risk: quality attribute gaps discovered late in development force process re-optimization, extended timelines, and potential cell line reselection. Media supplementation enables earlier intervention—tuning glycan distribution as a process parameter from the beginning of cell line and media development rather than as a remediation strategy.David Brühlmann outlines the experimental protocol for validating raffinose supplementation, including decision criteria for proceeding or terminating at...
2026-02-1715 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders227: Media-Based Glycan Engineering for Biosimilars: Achieving Reference Product MatchWhen your biosimilar analytical data shows 1.4% high mannose against a 6% reference product specification, you face limited options: process temperature shifts that compromise titer, kifunensine supplementation that requires extensive regulatory justification, or 12-18 months to reclone and revalidate. Media supplementation offers an alternative pathway—tuning glycan profiles through formulation adjustments rather than cell line or process re-engineering.In this episode, David Brühlmann presents the experimental development of a media supplementation strategy that achieved 2.8-fold increases in high mannose glycans across multiple CHO cell lines. Drawing from research published in the Journal of Biotechnology (2017, 252:32-42), the discussion covers the...
2026-02-1016 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders226: Mastering Radiopharmaceutical Development: Preclinical Model Selection for Clinical Success with Bryan Miller - Part 2Hard-to-treat cancers like pancreatic ductal adenocarcinoma (PDAC) have long defied conventional therapies. Radiopharmaceuticals, combining targeted therapy with diagnostic power, are creating new opportunities in precision oncology.Host David Brühlmann speaks with Bryan Miller of Crown Bioscience, who explains how Crown's strategic partnerships, rigorous quality standards, and adaptive study design are shaping radiopharmaceutical development—delivering speed, safety, and real clinical impact.In this episode, you'll learn:The promise and practical implications of theranostics—agents used for both diagnosis and treatment (02:44)Definitions and distinctions between CDX (cell line-derived xenograft) and PDX (patient-derived xenograft) models, and why P...
2026-02-0516 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders221: From 2D Cultures to Advanced 3D Cell Models for Preclinical Research with Catarina Brito - Part 1What if the failure rate in clinical trials isn't about picking the wrong drug candidates—but about testing them in the wrong models?When you move cells from a 2D culture plate into a bioreactor, you're not simply scaling volume. You're fundamentally changing the biological context. Cell density shifts. Mass transfer dynamics evolve. Mechanical cues emerge. The cells sense these changes and respond—often in ways that derail strategies built on oversimplified assumptions.Most preclinical research still relies on flat plastic surfaces and animal models that miss critical aspects of human biology. The result? Therapeutics fail...
2026-01-2019 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders220: From 10,000 Structures to 1.8 Billion Interactions: Breaking the Data Bottleneck to Engineer Efficacious Therapeutics with Troy Lionberger - Part 2The biotech industry stands on the verge of a radical transformation thanks to artificial intelligence (AI) and machine learning (ML). But even the most sophisticated algorithms are only as smart as the data feeding them.David Brühlmann sits down with Troy Lionberger, Chief Business Officer at A-Alpha Bio, whose team has quietly shattered the data ceiling by measuring and curating more than 1.8 billion protein interactions. Troy Lionberger brings an insider’s perspective from the frontlines of machine learning-powered drug discovery. From partnering with leading biotechs to redesigning classic antibodies for previously “impossible” targets, Troy’s work pushes th...
2026-01-1517 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders219: From 10,000 Structures to 1.8 Billion Interactions: Breaking the Data Bottleneck to Engineer Efficacious Therapeutics with Troy Lionberger - Part 1Antibody therapeutics have transformed modern medicine, but for many scientists, developing new candidates still feels like searching for a needle in a haystack—a slow, expensive, and unpredictable process. Structural biology and high-throughput data generation are now collapsing that haystack, offering unprecedented visibility into the molecular handshake that drives life: protein-protein interactions.In this episode, David Brühlmann sits down with Troy Lionberger, Chief Business Officer at A-Alpha Bio, for an in-depth discussion on protein-protein interactions and how advances in data generation and machine learning are transforming antibody discovery and drug development.Troy Lionberger shares his...
2026-01-1326 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders215: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya Burkov - Part 1Across biotech labs, researchers swim in oceans of process data: sensor streams, run records, engineering logs, and still, crucial decisions get stuck in spreadsheets or scribbled into fading notebooks. The challenge isn’t having enough information, it's knowing which actions actually move the needle in cell culture productivity, process stability, and faster timelines.This episode, David Brühlmann brings on Ilya Burkov, Global Head of Healthcare and Life Sciences Growth at Nebius AI. With a career spanning NHS medicine, regenerative research, and cloud infrastructure, Ilya Burkov has lived the leap from microscope to server room. He’s seen...
2025-12-1621 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders213: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe Licari - Part 1What if you could predict formulation failures before ever touching a pipette? Computational approaches are revolutionizing biologics development, replacing trial-and-error experimentation with predictive intelligence that catches stability issues early and accelerates your path from candidate selection to clinic.In this episode, David Brühlmann welcomes Giuseppe Licari, Principal Scientist in Computational Structural Biology at Merck KGaA. A chemist by training, Giuseppe transitioned from wet lab experimentation to the predictive power of in silico modeling. Today, he operates at the intersection of computational biology and CMC development, using digital tools to screen candidates for developability, predict formulation challenges, a...
2025-12-0925 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders211: When the Innovator Becomes the Patient: Manufacturing Reality vs. Patient Urgency with Jesús Zurdo - Part 1Real progress in cell and gene therapy shouldn’t be measured solely by scientific innovation, but by whether those innovations actually reach the patients who need them most.In this episode, David Brühlmann sits down with Jesús Zurdo, a scientist who’s spent three decades engineering life-changing biotechnologies, but whose outlook on the field shifted dramatically after becoming a leukemia patient himself.With experience on both sides of the system, Jesús Zurdo brings a rare, unfiltered perspective to the persistent gap between scientific promise and real-world patient access.Here’s why this...
2025-12-0221 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders206: Process Economics Decoded: How to Model Biomanufacturing Costs From Clinical to Commercial Scale with Niklas Jungnelius - Part 2Carbon neutrality goals are everywhere in biopharma. But how do you actually measure and reduce your true environmental impact when data gaps and baseline differences make comparisons so tough?In this episode, David Brühlmann talks with Niklas Jungnelius, Cytiva’s expert in process modeling and sustainability, who’s spent years uncovering what really drives emissions and how small process tweaks can deliver big results.Niklas goes beyond the numbers, challenging assumptions and showing how sustainability becomes a strategic, data-driven advantage. From real-world cases at Cytiva, he explains why recycling plastics may not move the needl...
2025-11-1317 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders205: Process Economics Decoded: How to Model Biomanufacturing Costs From Clinical to Commercial Scale with Niklas Jungnelius - Part 1Your 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 n...
2025-11-1125 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders204: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 2Cell 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 sn...
2025-11-0620 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders203: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 1Finding 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 D...
2025-11-0428 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders202: Fighting Antimicrobial Resistance: How AI Cuts Phage Therapy Access from 6 Months to 5 Days with José Bila - Part 2What 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 engin...
2025-10-3024 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development - Part 2Your 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.
2025-10-2320 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders199: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development - Part 1Over 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 F...
2025-10-2121 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders197: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda Hoertz - Part 1What if the key to unlocking ADC manufacturing success lies in abandoning the platform mindset entirely?Antibody-drug conjugates represent biotech's most promising weapon against cancer: precision-targeted therapeutics that deliver cytotoxic payloads directly to tumor cells while sparing healthy tissue. But beneath the clinical promise lies a manufacturing reality that's rewriting the rules of bioprocess development, demanding analytical strategies that most CDMOs simply aren't equipped to handle.In this deep-dive episode, David Brühlmann sits down with Amanda Hoertz, Vice President of Analytical and Formulation Sciences at KBI Biopharma, where she oversees 300+ scientists across the mammalian n...
2025-10-1425 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders196: Monolithic Chromatography Innovations: Solving High-Capacity Purification for Gene Therapy Vectors with Alois Jungbauer - Part 2What if solving tomorrow’s bioprocessing challenges meant questioning the very physics of chromatography and reimagining downstream processing from the ground up?For years, large biomolecules like viral vectors and exosomes have squeezed through the limitations of traditional chromatography, leaving scientists to wrestle with capacity trade-offs and slow mass transfer. But what if a fundamental shift could unlock breakthroughs for gene therapies, vaccines, and advanced biologics?In this thought-provoking episode, host David Brühlmann sits down with Alois Jungbauer, professor emeritus of downstream processing at BOKU University (Vienna) and scientific advisor at BioChromatographix International. Together, the...
2025-10-0925 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders195: Monolithic Chromatography Innovations: Solving High-Capacity Purification for Gene Therapy Vectors with Alois Jungbauer - Part 1In this episode, host David Brühlmann is joined by Alois Jungbauer, Professor Emeritus at BOKU University, Vienna, and Scientific Advisor at BioChromatographix International. With over 40 years in bioprocess engineering and more than 400 published papers, Jungbauer offers a unique perspective on how downstream processing and purification technologies have evolved and where they’re headed next.Alois shares his unconventional journey into the world of biotech, starting from humble beginnings on an Austrian farm, and discusses key turning points that have shaped the industry. Together, they explore the latest challenges triggered by high cell culture titers, new therapeutic mod...
2025-10-0720 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders194: Viral Vector CDMO Mastery: Singapore's Answer to Cell and Gene Therapy Supply Shortages with Lucas Chan - Part 2What if the future of affordable, life-changing cell and gene therapies comes down to one critical yet often overlooked factor: manufacturing efficiency?In advanced therapy medicinal products (ATMPs), groundbreaking science abounds, but the path to the clinic is still strewn with bottlenecks, especially when it comes to cost, complexity, and safety. While the promise is enormous, most therapies remain out of reach for many patients due to high cost of goods and logistical hurdles. What can actually break down these barriers and democratize access?In this episode, David Brühlmann welcomes Lucas Chan, celebrated Fellow o...
2025-10-0219 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders192: Process Intensification Secrets: A Process Engineer's Decision Framework with Andreas Castan - Part 2Is continuous manufacturing delivering the transformative results everyone promised, or are you being sold an expensive solution to the wrong problem? While industry headlines tout revolutionary productivity gains, the economic reality behind continuous bioprocessing tells a more nuanced story that every process engineer needs to understand before making capital investment decisions.In this episode, host David Brühlmann continues his conversation with Andreas Castan, Strategic Technology and Business Development Leader at Cytiva, diving deep into the hard economics and operational realities of next-generation manufacturing strategies. Andreas brings over 25 years of bioprocess expertise from upstream innovation t...
2025-09-2519 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders191: Process Intensification Secrets: A Process Engineer's Decision Framework with Andreas Castan - Part 1What if process intensification could transform your bioprocessing economics without the complexity most engineers fear? Getting 3x productivity gains and 30-150% titer increases once seemed reserved for Big Pharma's endless R&D budgets, but a strategic approach to technology selection is making these results achievable for companies of any size.In this episode, David Brühlmann speaks with Andreas Castan, a bioprocess veteran with over 25 years of industry experience who provides leadership and support to Cytiva's bioprocess business. Andreas brings deep expertise from directing upstream development at Swedish Orphan Biovitrum and extensive work in expression s...
2025-09-2321 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) - Part 2Still think you can "figure out CMC later"? Your competitors just implemented a systematic framework that cuts their IND timeline in half while you're still debating whether CMC matters.The founders who file INDs predictably aren't smarter than you. They just stopped gambling with ad-hoc CMC approaches and started executing proven systems. While you're wrestling with technical details in crisis mode, they built systematic advantages that turn regulatory complexity into competitive weapons.In this episode, host David Brühlmann delivers the complete five-step framework that transforms CMC from startup-killer into market advantage. This i...
2025-09-1818 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders189: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) - Part 1Think you can crack the science first and worry about CMC when you "need it"? That's exactly how promising therapies die in regulatory limbo while patients keep waiting.Your breakthrough discovery means nothing if it's trapped in CMC chaos. While you're perfecting your molecular mechanism, competitors with inferior science but superior CMC strategy are racing past you to IND filing and ultimately, to patients.In this episode, I, David Brühlmann, your usual host, expose the dangerous delusion that's quietly bankrupting biotech startups: the belief that brilliant science automatically translates to successful drug d...
2025-09-1616 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders187: From Biology Is Messy to Designable: The Smart Bioprocessing Transformation with Carmen Jungo Rhême - Part 1Almost every corner of modern medicine and sustainable food production today is facing a massive challenge: how do we outpace drug-resistant “superbugs” and create food for a growing population using fewer resources? The answer, it turns out, may come down to how well we understand and control the biomanufacturing processes underpinning these biomaterials and biomolecules.In this episode, David Brühlmann speaks with Carmen Jungo Rhême, Full Professor at the University of Applied Sciences in Fribourg, Switzerland and Director of the Biofactory Competence Center. With years in the pharmaceutical industry at Lonza, Merck Serono, UCB Farchim, and CS...
2025-09-0921 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders186: How Generative AI Accelerates Protein Design for Biotech Discovery with Elise de Reus - Part 2Imagine unlocking a world where designing custom proteins is not only feasible - but faster, smarter, and more powerful than ever before, thanks to artificial intelligence.As the promise of programmable biology takes center stage, AI-driven protein engineering is rapidly moving from theoretical dream to industry standard.In this episode, David Brühlmann sits down with Elise de Reus, co-founder of Cradle, whose ground-breaking platform has become a go-to for luminaries at pharma giants, as well as leaders in agriculture and industrial biotech. Elise’s journey bridges hands-on scientific discovery with entrepreneurial vision, and she’s on...
2025-09-0417 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders185: How Generative AI Accelerates Protein Design for Biotech Discovery with Elise de Reus - Part 1For decades, protein design has hinged on painstaking rounds of wet lab mutagenesis and trial-and-error, a process limited not by human ingenuity, but by time and complexity. Yet as the biotech field seeks faster, greener, and more effective solutions for therapeutics and industrial applications, the next leap might not come solely from the lab bench.In this episode, host David Brühlmann explores the frontiers of AI-driven protein engineering with Elise de Reus, co-founder of Cradle. Elise’s journey weaves together a passion for DNA, real-world impact from the dairy industry to synthetic biology, and high-throughput experience at...
2025-09-0224 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee Ho - Part 2What’s the secret to turning a cutting-edge scientific breakthrough into a commercial biotech success?For every inspiring lab discovery, countless prototypes stall before ever reaching the market. The barriers? Securing the right beta testers, outmanoeuvring industry giants, and building teams who understand not just the science, but the user experience from bench to bedside.In this episode of the Smart Biotech Scientist Podcast, David Brühlmann welcomes Chervee Ho, CEO & Co-Founder of BioChromatographix International. Chervee isn’t just developing breakthrough column technologies - she’s navigating the trenches of commercialization, from resource-stretched startups to partner...
2025-08-2819 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders183: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee Ho - Part 1Every year, cutting-edge biomedical technologies are left stranded in the lab, not for lack of innovation, but because they miss the crucial leap from technical performance to genuine industry adoption. The gap between scientific brilliance and commercial success is deceptively simple: deeply understanding and building for your customer’s real-world pain points.In this episode, David Brühlmann welcomes Chervee Ho, CEO & Co-Founder of BioChromatographix International. With a background at the intersection of biotechnology and commercial strategy, Chervee has helped reshape how startups approach product development to actually get adopted in conservative markets. From her early days in...
2025-08-2624 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders182: Innovating Continuous Bioprocessing with Vibrating Membrane Filtration with Jarno Robin - Part 2What if the secret to making continuous bioprocessing practical, sustainable, and far simpler has been shaking - literally - just beneath our feet?For years, the industry has grappled with the complexities of continuous manufacturing, with technologies like ATF (alternating tangential flow) steadily dominating the perfusion landscape. But what if there's a game-changer right around the corner - a technology that vibrates membranes, not workflows, promising both higher performance and a greener footprint?Enter Jarno Robin, a pioneering force in membrane filtration and Pharma Business Development Director at Sani Membranes. With two decades of experience i...
2025-08-2117 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders181: Innovating Continuous Bioprocessing with Vibrating Membrane Filtration with Jarno Robin - Part 1What if one of biotech’s biggest production breakthroughs was hiding in plain sight? Not in a new gene or a wonder drug, but in the way we process and purify biologics.Perfusion technology, once dismissed as a pipedream in top biopharma boardrooms, is now quietly powering some of the industry’s most efficient and productive manufacturing platforms. Yet, transforming perfusion from controversial buzzword to gold standard required timing, vision, and a willingness to break from tradition.In this episode, host David Brühlmann sits down with Jarno Robin, a bioprocessing pioneer whose 20+ year journey spans...
2025-08-1925 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders179: How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davies - Part 1The key to conquering autoimmune diseases and type 1 diabetes may lie not in replacing lost cells, but in retraining the immune system using cells already within the body.Biotech is increasingly exploring stem cell therapies, but a quieter revolution is brewing: stromal cell therapy. These master “coordinators” aren’t about rebuilding tissues molecule by molecule - instead, they orchestrate an anti-inflammatory response, offering new hope for conditions once considered incurable.In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann speaks with Lindsay Davies, a leading expert in advanced therapies. She is the CSO...
2025-08-1223 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders178: Rethinking Cultivated Meat Production: Scale and Media Optimization Strategies Slashing Manufacturing Costs with Richard Alldread - Part 2The promise of cultured food is undeniable: delicious, sustainable meat and fish grown without the need for traditional farming. But the journey from lab bench to supermarket shelf is filled with complex regulatory, technological, and consumer acceptance challenges. The big question: how do we transform small-scale breakthroughs into global food production realities?In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann sits down with Richard Alldread, CTO of The Cultured Hub - a unique joint venture between Givaudan, Bühler, and Migros - positioned at the intersection of flavor, food processing, and retail ex...
2025-08-0721 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders177: Rethinking Cultivated Meat Production: Scale and Media Optimization Strategies Slashing Manufacturing Costs with Richard Alldread - Part 1What if the secrets to feeding the planet - and democratizing access to future protein - were hiding in the core toolkit of biopharma?The worlds of biopharmaceuticals and cultured food may seem galaxies apart, but at their heart, both rely on remarkably similar technology: media, bioreactors, and cell processing. Yet, as demand grows for sustainable, affordable protein for the masses, innovators are confronting a challenge bigger than scale.This week, host David Brühlmann welcomes Richard Alldread, Chief Technology Officer at The Cultured Hub, a groundbreaking joint venture between three Swiss industry leaders that s...
2025-08-0523 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders176: How Virtual Reality Training Solves Europe's Bioproduction Talent Shortage with Sandrine Lemoine - Part 2What if the missing link to resilient European bioproduction is not just another breakthrough technology, but the ability to continuously learn, adapt, and collaborate?In a rapidly shifting biotech landscape, innovation isn’t only driven by technical prowess. Behind every robust production process and every cutting-edge therapy, there’s a team empowered with both technical expertise and the soft skills necessary to thrive.In this episode, host David Brühlmann explores the human side of bioproduction with Sandrine Lemoine, CEO of Immerscio.bio, who has dedicated her career to transforming talent development in the industry. Sandr...
2025-07-3114 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders175: How Virtual Reality Training Solves Europe's Bioproduction Talent Shortage with Sandrine Lemoine - Part 1What if the road to bioproduction mastery started not in the lab, but with how you train your people?Traditional biotech education often ends at theory, leaving graduates unprepared for the fast-paced world of manufacturing. But what if the key to faster, safer, and more scalable bioprocessing is digital immersion, letting scientists train in a virtual facility before they ever enter a real one?This week, David Brühlmann welcomes Sandrine Lemoine, CEO of Immerscio.bio, to the Smart Biotech Scientist Podcast. With over 25 years spanning R&D, manufacturing strategy, and executive coaching, Sandrine has s...
2025-07-2919 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders174: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist Gernaey - Part 2How do you transform hybrid model digital twins from promising lab concepts into commercial bioprocessing game-changers that actually deliver ROI?As biotech companies race to implement Industry 4.0 technologies, the critical challenge isn't just developing sophisticated hybrid models - it's deploying them strategically to create user-friendly, cost-effective solutions that genuinely accelerate your path to commercial bioprocessing success.In Part 2 of this essential conversation, David Brühlmann continues his deep dive with Krist Gernaey, Professor of Industrial Fermentation Technology at the Technical University of Denmark. Krist reveals the strategic framework for moving beyond digital twin hype to b...
2025-07-2420 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders173: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist Gernaey - Part 1Are you struggling to bridge the gap between lab-scale models and commercial bioprocessing reality? For many biotech innovators, the promise of digital twins meets harsh industrial constraints - where hybrid models that excel in controlled lab environments must prove themselves in the complexity of large-scale manufacturing.This week on the Smart Biotech Scientist Podcast, host David Brühlmann welcomes Krist Gernaey, Professor of Industrial Fermentation Technology at the Technical University of Denmark. With expertise spanning measurement technology development and two decades pioneering hybrid model digital twins for bioprocess applications, Krist reveals the critical gap between digitalization hype a...
2025-07-2222 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders172: Reimagining Chromatography for Advanced Therapies: From Diffusion to Convection with Scott Wheelwright - Part 2Downstream processing remains one of the most complex and critical steps in biomanufacturing, especially as new therapeutic modalities like cell and gene therapies push current technologies to their limits. The industry faces ongoing pressure to innovate, reduce costs, and improve efficiency, while still ensuring robust and reliable results.In this practical, energetic episode, host David Brühlmann welcomes Scott Wheelwright, Chairman, CTO and Co-Founder of BioChromatographix International (BCI). With a career spanning continents - Asia, Europe, and North America - Scott's perspective is forged from hands-on manufacturing, technology transfer, and building high-growth companies from scratch. He’s not...
2025-07-1719 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders171: Reimagining Chromatography for Advanced Therapies: From Diffusion to Convection with Scott Wheelwright - Part 1For decades, chromatographic purification has made use of bead-based diffusion - a reliable but limiting approach, especially as new modalities like gene therapies, mRNA, and viruses push the boundaries of what’s possible. But what if the future of downstream processing lies not in incremental improvement, but in a dramatic reimagining - from slow diffusion to rapid convection?In this episode, David Brühlmann meets Scott Wheelwright, Chairman, CTO and Co-Founder of BioChromatographix International (BCI). Scott brings decades of expertise in biopharmaceutical development and manufacturing. Prior to BCI, he co-founded Biolnno Bioscience, a leading CDMO, and co-founded Inn...
2025-07-1520 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders170: Why Your DNA Is a Terrible Disease Predictor (And How Multi-Omics Changes Everything) with Mo Jain - Part 2For years, disease diagnosis and treatment have focused on a few biomarkers, overlooking thousands of vital biological signals. Despite biotech advances, most therapies are still based on limited data, missing countless breakthroughs.Multiomics changes that. By analyzing tens of thousands of proteins, metabolites, and lipids, it reveals hidden insights, paving the way for smarter, faster, and more effective medical discoveries.In this must-listen episode, David Brühlmann welcomes Mo Jain, founder and CSO of Sapient, a pioneering force in bringing multiomic platforms out of academia and into the heart of drug development. A physician-scientist by t...
2025-07-1024 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders169: Why Your DNA Is a Terrible Disease Predictor (And How Multi-Omics Changes Everything) with Mo Jain - Part 1What if the secret to truly personalized precision medicine lies not in your genetic code, but in your zip code?For years, biotech has focused on genomics to explain disease and drug response, but DNA only accounts for a fraction of the story. The real breakthrough? Multi-omics: the large-scale analysis of proteins, metabolites, and lipids, powered by advanced mass spectrometry and AI, offering a fuller picture of human health.In this episode, David Brühlmann meets Mo Jain, founder and CSO of Sapient, a leader in multi-omics analytics. With over two decades of experience across p...
2025-07-0827 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders168: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet Satwekar - Part 2The promise of generative AI in pharma and biotech is huge, but it's also fraught with complexity, especially when it comes to integrating these systems into highly regulated environments. From monitoring evolving guidelines to balancing operational efficiency and data integrity, the journey from hype to real-world impact is filled with both opportunity and skepticism.In this episode, David Brühlmann sits down with Abhijeet Satwekar, Innovation Manager at Merck Healthcare’s Global Analytical Development. Abhijeet has spent years on the front lines of digital transformation in the biotech sector, and his current mission: implementing generative AI for reg...
2025-07-0326 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders167: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet Satwekar - Part 1Ever feel like you’re drowning in an ocean of constantly shifting regulatory guidelines? The world of biotech is a whirlwind of evolving standards, making compliance not just a headache, but sometimes the stumbling block between life-changing therapies and the patients who need them. But what if artificial intelligence could turn regulatory chaos into your biggest competitive advantage?In this episode, David Brühlmann sits down with Abhijeet Satwekar, Innovation Manager at Merck KGaA’s Global Analytical Development. Abhijeet shares how he’s pioneering the use of generative AI, not as a hype machine, but as a practic...
2025-07-0115 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders166: Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It) - Part 2Have you ever presented a major scientific breakthrough, only to be met with blank stares and distracted executives? You're not alone. In this episode, David Brühlmann shares how he went from drowning in data to winning an innovation contest, not through better tech, but through the power of scientific storytelling.Many scientists default to methods and data, but as David notes, “it’s like being fluent in a language nobody else in the room speaks.” Without a clear link to human impact, even the most brilliant work can go unnoticed.Key insights from the episode...
2025-06-2617 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders165: Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It) - Part 1Have you ever poured months of research into a brilliant innovation, only to watch executives’ eyes glaze over during your presentation? You’re not alone. In this episode, host David Brühlmann describes a familiar frustration: scientists are trained to perfect data, not to sell ideas. But in today’s fast-paced biotech landscape, even the most groundbreaking technology risks fading into obscurity if it isn’t communicated effectively.Here’s what you’ll learn in this episode:Why Good Science Needs Great Storytelling: David Brühlmann shows that the most funded projects are often the best-commu...
2025-06-2418 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders164: How Moss Enables Production of Unproducible Protein Therapeutics with Andreas Schaaf - Part 2From lab curiosity to commercial reality. Here's what happens when moss meets the brutal economics of bioprocessing.In Part 1, you've heard the science behind moss-based protein production. Now comes the real test: Can it survive the gauntlet of regulatory scrutiny, cost pressures, and manufacturing scale-up that crushes most biotech innovations?In Part 2 of this groundbreaking conversation, David Brühlmann and Andreas Schaaf, Managing Director and CSO of Eleva, dive into the nuts and bolts of what it actually takes to commercialize a revolutionary production platform. Andreas doesn't just theorize—he's lived through 15+ years of transforming Ele...
2025-06-1921 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders163: How Moss Enables Production of Unproducible Protein Therapeutics with Andreas Schaaf - Part 1What if the future of "impossible" protein therapeutics is hiding in your backyard?For decades, CHO cells have ruled the biotech kingdom as the undisputed champions of complex protein production. But here's the uncomfortable truth: countless breakthrough therapies are gathering dust on laboratory shelves—not because the science failed, but because traditional hosts can’t produce them.Enter moss. Yes, moss. That humble green organism clinging to rocks and trees might just be the biotech industry's best-kept secret.In this eye-opening episode, David Brühlmann sits down with Andreas Schaaf, Managing Director and CSO o...
2025-06-1725 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders162: How to Achieve 85%+ Cell Recovery Without DMSO's Toxic Side Effects with Jeffrey Allen - Part 2The world of cell therapy is changing rapidly, with revolutionary advancements in cryopreservation and bioprocessing protocols leading the way. In a recent episode of the Smart Biotech Scientist Podcast, host David Brühlmann sat down with Jeffrey Allen, Chairman and CEO of Evia Bio, to dive deep into the “how” of implementing cutting-edge techniques in the lab and the strategic mindset needed to move therapies from concept to clinic successfully.Jeffrey Allen is a passionate leader with a diverse background in shaping strategy, building high-performing teams, and driving exceptional results across public and private equity-backed organizations. With exten...
2025-06-1215 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders156: The Hidden Economics of Continuous Processing That Most Biotech Companies OverlookThe world of biologics manufacturing is undergoing a major transformation. Once dominated by traditional batch processes, the industry is now experiencing a marked shift toward continuous bioprocessing.But as companies contemplate this transition, two questions dominate strategic discussions: Will regulators accept continuous manufacturing? And, perhaps more pressingly, Does the business case justify making the switch?In this podcast episode of the Smart Biotech Scientist Podcast, David Brühlmann dives into these pivotal topics - drawing insights from real-world case studies, regulatory updates, and economic analyses.Top three takeaways:Regulators Are On Board: T...
2025-05-2227 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders155: From Process Bottlenecks to Seamless Production: How Continuous Bioprocessing Changes EverythingIn this episode of the Smart Biotech Scientist Podcast, host David Brühlmann dives into continuous bioprocessing - a major shift in biologics manufacturing that's turning traditional batch processes into streamlined, real-time operations.Imagine running your biologics process non-stop for 30 days, with smart monitoring and smaller, more efficient systems replacing massive reactors. It’s not just possible - it’s already happening across the industry, from Amgen’s 80% smaller facility to Sanofi’s modular "Factory of the Future."David explores how companies - big and small - are increasing productivity, cutting costs, and reducing waste through c...
2025-05-2025 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders152: Is an Indian CDMO the Right Move for Your Biologics Pipeline? with Abdelaziz Toumi - Part 2Is 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...
2025-05-0821 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders151: Is an Indian CDMO the Right Move for Your Biologics Pipeline? with Abdelaziz Toumi - Part 1Is 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 p...
2025-05-0628 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders150: How to Leverage AI in Media Development Without Sacrificing Process Understanding with Tom Fletcher - Part 2As 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 s...
2025-05-0125 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders149: How to Leverage AI in Media Development Without Sacrificing Process Understanding with Tom Fletcher - Part 1From 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 o...
2025-04-2918 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders144: The Future of Biotech: Making Biotherapeutics More Accessible FasterImagine 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-m...
2025-04-1012 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders143: Bioprocess Breakthroughs: How Smart Bioprocessing Is Democratizing Life-Saving TreatmentsIn 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 b...
2025-04-0815 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders141: How Microalgae Cuts Antibody Costs by 70% and Redefines Biomanufacturing with Muriel Bardor - Part 1The 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...
2025-04-0126 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders140: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel - Part 2In 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...
2025-03-2720 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders139: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel - Part 1In 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.
2025-03-2527 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders137: Skip 90% of Bioreactor Runs: The In Silico Revolution in Bioprocess Development with Yossi Quint - Part 1The 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 Y...
2025-03-1821 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)Sickle cell disease affects thousands with severe daily pain. While FDA-approved gene therapies exist, their $2.2 million cost per treatment makes them largely inaccessible.In this episode of the Smart Biotech Scientist Podcast, David Brühlmann explores five key challenges facing the bioprocessing industry in making these therapies more accessible:Moving Away from Platform TechnologiesTraditional bioprocessing relies on platform technologies for antibody production. However, new therapies require more flexible, adaptable systems that can accommodate novel modalities.Increased Personalization and Smaller Batch SizesPersonalized medicine, especially a...
2025-03-1313 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders135: Beyond Breakthroughs: Making Biotherapeutics Affordable for AllIn 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 rev...
2025-03-1112 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders134: Seamless Seed Trains: Simplify Without Sacrificing Quality with François Carruzzo - Part 2The 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.Her...
2025-03-0616 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders131: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza Farahani - Part 1The 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 b...
2025-02-2528 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster - Part 2The 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 ca...
2025-02-2020 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders127: The 7 Hidden Innovation Habits That Top Biotech Scientists Use Daily - Part 1In 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...
2025-02-1115 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei - Part 2As 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 d...
2025-02-0620 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders125: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei - Part 1Intracellular 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 n...
2025-02-0421 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders122: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger - Part 2In 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 t...
2025-01-2317 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders121: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger - Part 1Digital 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 b...
2025-01-2124 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian Guo - Part 2In 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 s...
2025-01-1621 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders119: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian Guo - Part 1Biotechnology 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 pur...
2025-01-1419 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders115: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy Agresti - Part 1Bioprocess 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. W...
2024-12-1719 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders107: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer - Part 1Ever 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 mor...
2024-11-1919 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders101: PAT Revolution: Decoding Your Bioprocess Like Never Before with Katharina Dahlmann - Part 1Unlock the hidden potential of your bioprocess! In this eye-opening episode, David Brühlmann sits down with Katharina Dahlmann, Application and PAT Expert at Hamilton, to explore the game-changing world of Process Analytical Technology (PAT).Discover how PAT is revolutionizing biotech by providing unprecedented insights into cell behavior and process dynamics. Katharina challenges conventional wisdom, revealing that what we think we know about our processes may just be the tip of the iceberg. Learn how combining multiple PAT signals can extract meaningful knowledge, leading to more reproducible and efficient processes.You will gain valuable insights o...
2024-10-2924 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders97: The Biomanufacturing Revolution: Bringing Game-changing Products to Market with James Ryall - Part 1In this captivating episode, host David Brühlmann welcomes James Ryall, a strategic consultant with over two decades of experience in cell biology and regenerative medicine. From his groundbreaking work in skeletal muscle research to revolutionizing cultured meat production, James shares his fascinating journey through academia and industry.Discover how he's now helping biotech startups align their technical strategies with commercial outcomes, accelerating their path to market.You will gain invaluable insights on:Navigating the transition from academia to industryScaling cell production from lab quantities to industrial volumesIdentifying and pivoting to the right target m...
2024-10-1526 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders96: AI in Bioprocess Development: The Game-Changer You Can't Ignore with Belma Alispahic - Part 2Are you ready to revolutionize your bioprocess development? Join David Brühlmann as he interviews Belma Alispahic, Chief Scientific Officer and Co-Founder of AnalysisMode, who unveils the game-changing potential of AI in biopharma.Discover how AI is transforming the industry, from drug discovery to manufacturing, and learn why it's no longer optional but essential for success.Key takeaways:Leverage AI to streamline experiments, reduce costs, and accelerate your path to marketGain insights into emerging AI technologies reshaping biopharma's futureLearn practical steps to integrate AI into your workflow, even with limited resourcesDon't miss t...
2024-10-1019 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders88: The Swiss Army Knife of Biotech: Unleashing the Power of Fractional ExpertiseUnlock the secret weapon of biotech success! In this eye-opening episode, host David Brühlmann reveals how fractional CTOs are revolutionizing drug development, inspired by Michael Jordan's approach to greatness. Learn how this innovative strategy can slash timelines, mitigate risks, and give your biotech company a competitive edge.Discover the game-changing benefits of fractional expertise:Gain rapid access to broad biotech knowledge, navigating complex challenges with ease.Slash costs while tapping into C-level strategic guidance for critical growth phases.Accelerate business development through valuable industry connections and insights.Ready to transform your biotech journey? Tune i...
2024-09-1216 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders87: The Hidden Pitfalls of Bioprocess Development: Lessons from the TrenchesUnlock the secrets of successful bioprocess development with host David Brühlmann as he shares hard-won lessons from his 15+ years of experience leading technology transfers and technology innovation projects.Discover why prioritizing process development is crucial for transforming groundbreaking science into life-changing therapies. In this eye-opening episode, you'll learn:How to avoid costly mistakes in technology transfer and scale-up, saving you time and resourcesStrategies for balancing investor expectations with regulatory hurdles, keeping your project on trackTips for building a robust risk management strategy that impresses investors and navigates challengesFrom selecting the right cell lines t...
2024-09-1016 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls w/ Matthias Müllner - Part 2Dive into the realm of biotech with our latest episode as we unravel the enigma of Quality by Design (QbD) with Matthias Müllner, CEO of & Co-Founder bespark*bio, a company empowering viral vector-based medicines.Discover how integrating QbD principles early in your development cycle can revolutionize your approach to producing safe, high-quality products consistently. From understanding critical quality attributes to designing robust manufacturing processes, we illuminate the transformative potential of QbD.Key Takeaways:Harnessing QbD principles empowers biotech companies to design quality into processes, fostering a deeper understanding of critical parameters and ensuring p...
2024-05-3019 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders57: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls w/ Matthias Müllner - Part 1Join us for an insightful episode as we dive into the world of bioprocess CMC development strategies with Matthias Müllner, CEO of & Co-Founder bespark*bio, a company empowering viral vector-based medicines.Matthias shares his wealth of knowledge on avoiding common pitfalls in developing robust Chemistry, Manufacturing, and Controls (CMC) strategies. He also emphasizes the critical elements that ensure your biotech product's success.Key Takeaways:Start Strong: Establishing a comprehensive CMC plan early can prevent costly and time-consuming issues later.Leverage Expertise: Bringing in external CMC consultants early o...
2024-05-2817 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders24: Strategies for Success: Master CMC Development with Gene Lee - Part 2If you've ever wondered how to seamlessly transition from R&D to process development, this is your golden ticket. Uncover practical strategies and expert advice that can be your compass through the intricate landscape of mastering CMC development.Uncover the challenges and tactics to seamlessly navigate this critical phase.Conduct Early Developability Assessments: By assessing productivity, aggregation propensity, and manufacturability early on, you can strategically avoid future roadblocks.Use a Platform: A platform approach facilitates swift and cost-effective transitions to clinical trials, reducing pre-proof of concept investment.Bridge the R&D and Process Development Gap: Navigating...
2024-02-0122 minSmart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders23: Strategies for Success: Master CMC Development with Gene Lee - Part 1Embark on a journey into the intricate world of CMC development with our latest episode, unraveling the challenges that often baffle biotech scientists. The complexity of CMC development is a formidable hurdle, and in this insightful discussion, we delve into strategies to master this critical process.Key Takeaways:Start Early: Learn how starting CMC development early, even without a complete understanding of your drug, can reduce risks and prepare you better for clinical milestones.Collaborate: CMC development should not work in isolation but integrate insights from diverse teams for a comprehensive drug development strategy.Adopt a...
2024-01-3018 min