Search a title or topic

Over 20 million podcasts, powered by 

Player FM logo

Biotech C Level Advisor Podcasts

show episodes
 
Artwork

4
Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist

icon
Unsubscribe
icon
icon
Unsubscribe
icon
Weekly+
 
The Go-to Podcast for Biotech Scientists Who Want to Master Biopharma CMC Development and Biomanufacturing. **TOP 10 LIFE SCIENCES PODCAST** Are you ready to simplify bioprocess development and scale with confidence to reduce time to market? Are you feeling overwhelmed by the complexity and guesswork of biologics development and biomanufacturing? Do you wish you had more time to enjoy the beauty of science, without worrying about failing your cell culture process development and commercializ ...
  continue reading
 
Welcome to “A Dose of Reality”, the podcast where we infuse insight, laughter, and practical wisdom into the world of clinical leadership and career development. Hosted by Charles Spence, each episode offers a deep dive into the challenges and triumphs of clinical leadership, providing listeners with meaningful conversations, career insights, and a dose of inspiration to navigate their professional journeys. Whether you're a director, a C-level executive, or a clinical researcher in oncology ...
  continue reading
 
Loading …
show series
 
In this episode, I talked with Sven Van den Berghe, CEO of Pantera, about his 25+ years in nuclear physics, from his early days at the Belgian Nuclear Research Center to stepping into the high-stakes world of radioisotope production. Sven speaks openly about the toughest move of his career: leaving the safety of a government research institute to r…
  continue reading
 
Carbon 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 rea…
  continue reading
 
Your Manufacturing Decisions Are Costing You More Than You Think Every 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 framewo…
  continue reading
 
In this episode, I talked with Catello Somma, Partner at Seroba, to learn about his nonlinear journey from academia and biopharma into venture capital—and the realities behind building funds, backing biotech founders, and surviving industry downturns. Catello shares the turning points that shaped his career: walking away from his PhD to get closer …
  continue reading
 
Cell and gene therapies are transforming modern medicine, but their path to market is fast and complex. They often jump from small trials to global launch at record speed, putting pressure on analytics, supply chains, and partnerships. Success depends on making smart choices about what to build in-house and what to entrust to expert partners. Danie…
  continue reading
 
Finding an analytical CRO that's truly invested in your success, not just processing samples, makes all the difference in CMC development. In this episode, host David Brühlmann talks with Daniel Galbraith, Chief Scientific Officer at Solvias, about the essential questions and mindset that lead to breakthrough CRO partnerships. With nearly three dec…
  continue reading
 
What if the answer to battling antibiotic-resistant infections isn’t a new antibiotic, but harnessing viruses that have been quietly dominating bacterial populations? Bacteriophages, viruses that target and kill bacteria, have been saving lives for a century, but their true potential is only now being unlocked by modern machine learning. The race i…
  continue reading
 
Antibiotic resistance isn’t just a looming problem. It’s a global crisis. Every year, more than one million people die directly from resistant infections, and another 5 million die indirectly. Routine infections are becoming life-threatening, and healthcare systems worldwide are under pressure. Despite decades of warnings, pharmaceutical solutions …
  continue reading
 
In this episode, I talked with Dr. Kevin Heller, former biotech CMO and now advisor to VCs and funds, who’s built his career at the intersection of science, leadership, and investment. Kevin started out as a pediatric hematologist–oncologist before joining BMS, where he worked on one of the first checkpoint inhibitor programs. Since then, he’s held…
  continue reading
 
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 …
  continue reading
 
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 …
  continue reading
 
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 Biop…
  continue reading
 
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 manu…
  continue reading
 
In this episode, I talked with Dr. Carl Deutsch, Chief Scientific Officer at NBE Therapeutics, where he shared about his path from chemistry into pharma and the lessons he’s learned along the way. Carl recalls how difficult it was to secure his first role when jobs were scarce, the pressure of multiple interview rounds, and how a non-linear career …
  continue reading
 
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 a…
  continue reading
 
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 technologi…
  continue reading
 
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 safet…
  continue reading
 
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…
  continue reading
 
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 …
  continue reading
 
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. I…
  continue reading
 
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 y…
  continue reading
 
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 strateg…
  continue reading
 
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? Carme…
  continue reading
 
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 bioma…
  continue reading
 
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 Br…
  continue reading
 
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 ben…
  continue reading
 
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 expe…
  continue reading
 
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-worl…
  continue reading
 
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 …
  continue reading
 
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…
  continue reading
 
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…
  continue reading
 
In this episode, I talked with Dr. András Strassz, Chief Medical Officer at Heidelberg Pharma, to hear about his two decades of leadership in oncology drug development—and the often-overlooked realities behind building teams, designing clinical trials, and making biotech work. András opens up about key moments in his career, including the personal …
  continue reading
 
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 mole…
  continue reading
 
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 pr…
  continue reading
 
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 sustainab…
  continue reading
 
In this episode, I talked with Dr. Steven Katz, CMO and SVP of Translational Science for Shinobi Therapeutics, a biotech company pioneering off-the-shelf immune-evasive IPSC-derived cell therapies, and Professor of Surgery at Brown University. We get into why technical skills alone won’t cut it—and how the wrong hire, even if they look great on pap…
  continue reading
 
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 emp…
  continue reading
 
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 vi…
  continue reading
 
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, cos…
  continue reading
 
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 …
  continue reading
 
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 thi…
  continue reading
 
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 …
  continue reading
 
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 ins…
  continue reading
 
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, powere…
  continue reading
 
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 opport…
  continue reading
 
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 i…
  continue reading
 
Loading …
Copyright 2025 | Privacy Policy | Terms of Service | | Copyright
Listen to this show while you explore
Play