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

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.

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 F...

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...

What if the key to unlocking ADC manufacturing success lies in abandoning the platform mindset entirely?

Antibody-drug conjugates represent biotech's most promising weapon against cancer: precision-targeted therapeutics that deliver cytotoxic payloads directly to tumor cells while sparing healthy tissue. But beneath the clinical promise lies a manufacturing reality that's rewriting the rules of bioprocess development, demanding analytical strategies that most CDMOs simply aren't equipped to handle.

In this deep-dive episode, David Brühlmann sits down with Amanda Hoertz, Vice President of Analytical and Formulation Sciences at KBI Biopharma, where she oversees 300+ scientists across the mammalian n...

What 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...

In 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...

What 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...

Viral vectors are the backbone of cutting-edge cell and gene therapies, delivering life-altering treatments to patients with genetic diseases. But making these biological delivery vehicles is a high-wire act: unpredictable, complex, and fraught with hurdles that traditional biologics manufacturers have never faced.

While the world races toward next-generation therapies, the challenge of producing viral vectors at clinical and commercial scale threatens to leave patients waiting on the sidelines.

Our guest on the Smart Biotech Scientist Podcast is Lucas Chan, a molecular and cell biologist with over two decades of hands-on experience in cell and gene...

Is 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...

What 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...

Still 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...

Think 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...

For too long, biotech innovators have viewed biological systems as inherently messy, unpredictable, and full of “black box” mysteries. But what if, armed with the latest digital tools, AI, and cross-disciplinary thinking, you could transform bioprocessing from a series of trial-and-error experiments to a streamlined, proactive design process?

Carmen Jungo Rhême is Full Professor at the University of Applied Sciences in Fribourg (HEIA-FR) and Director of the Biofactory Competence Center (BCC). With 17 years in the pharmaceutical industry at companies like Lonza, Merck Serono, UCB Farchim, and CSL Behring, she specializes in bioprocess development, protein purification, scale-up, and t...

Almost every corner of modern medicine and sustainable food production today is facing a massive challenge: how do we outpace drug-resistant “superbugs” and create food for a growing population using fewer resources? The answer, it turns out, may come down to how well we understand and control the biomanufacturing processes underpinning these biomaterials and biomolecules.

In this episode, David Brühlmann speaks with Carmen Jungo Rhême, Full Professor at the University of Applied Sciences in Fribourg, Switzerland and Director of the Biofactory Competence Center. With years in the pharmaceutical industry at Lonza, Merck Serono, UCB Farchim, and CS...

Imagine 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...

For 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...

What’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...

Every 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...

What 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...

What 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...

The promise of advanced cell therapies is undeniable, but as demand skyrockets, the challenges of taking a living drug from bench to bedside have never been greater. Each batch brings variability, each jurisdiction adds regulatory hurdles, and every strategic decision can determine whether a lifesaving therapy reaches patients or fizzles out behind clinical barriers.

Lindsay Davies is a leading figure in the cell and gene therapy field, serving as Vice President-Elect for Europe at the International Society of Cell and Gene Therapy (ISCT). She is Chief Scientific Officer at NextCell Pharma, co-founder of QVance, and founder of...

The 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...

The 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...

What 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...

What 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...

What 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...

How 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...

Are 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...

Downstream 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...

For 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...

For 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...

What 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...

The 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...

Ever 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...

Have 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...

Have 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:

From 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...

What 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...

The 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...

If you’ve ever worked in a cell therapy lab or handled biologics, you’ve probably experienced the pitfalls of cryopreservation. We’ve all mourned the loss of precious samples after a freeze-thaw cycle gone wrong or watched viability figures plummet, wondering where it all went awry.

In this episode of The Smart Biotech Scientist Podcast, Jeffrey Allen, Chairman and CEO of Evia Bio, shares how nature-inspired solutions are changing the cell preservation game. With a background spanning finance, operations, and leadership across the biotech landscape, Jeffrey brings a unique perspective on bridging science and practical manufacturing needs...