Claim OwnershipSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
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Description
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 commercialization?
There's a way to simplify and streamline so you can remove complexity, skip trials and errors, deliver your groundbreaking therapy to clinics and market without delay, and still enjoy every single step.
I'm David Brühlmann, a biotech entrepreneur and strategic advisor who partners with C-level biopharma leaders to tackle one of our industry's biggest challenges: reducing manufacturing costs to make lifesaving therapies accessible to more patients worldwide.
Through engaging conversations with industry pioneers and practical insights from the trenches, this podcast tackles the critical challenges in bioprocess CMC development and manufacturing of recombinant proteins and cell and gene therapy products. We cut through the complexity so you can:
- Master bioprocess development with confidence and clarity
- Excel at scale-up and manufacturing of biologics
- Transform your innovative therapy and manufacturing technology into market-ready solutions faster
- Optimize manufacturing costs without compromising quality
- Make data-driven decisions that reduce the risk of failure
I can’t wait to help you do biotech the smart way.
Grab a cup of coffee and your favorite notebook and pen. Now is the time to take your bioprocessing game to the next level.
Ready to transform your biomanufacturing journey? Let's dive in!
Next Steps:
Book a free call to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/call
🧬 Ready to accelerate your IND timeline? Get the proven CMC Dashboard that's guided successful mAb programs from chaos to submission: https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders
Accelerate biologics development with expert guidance: https://bruehlmann-consulting.com
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Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
217 Episodes
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Biomanufacturing has always dealt with the challenge of turning vast, complex datasets and intricate production steps into life-changing therapies. But when batch records multiply and process deviations loom, how do biotech teams make sense of it all? In this episode, we move beyond theory to the nuts and bolts of how AI - when thoughtfully deployed - can turn bioprocessing chaos into actionable intelligence, paving the way for the factory of the future. Our guest, Ilya Burkov, Global Head of...
Across 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...
Computational methods can predict stability issues before the lab. But how do you actually implement these approaches in your formulation workflow? From excipient selection to long-term stability prediction, in silico tools are transforming how biotech teams develop robust formulations while reducing costly trial-and-error cycles. In Part 2, Giuseppe Licari, Principal Scientist in Computational Structural Biology at Merck KGaA, returns to share practical implementation strategies for integrat...
What 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 w...
What happens when cell therapy innovation meets real patient urgency? In this conversation, the barriers between scientist and patient all but vanish, bringing clarity—and a new sense of mission—to some of the biggest problems facing advanced therapy manufacturing and delivery. Meet Jesús Zurdo, a biotech leader whose three decades of experience in innovation took on a whole new perspective when he became a leukemia patient himself. Seamlessly straddling the worlds of industry and patient car...
Real 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 pe...
From pandemic-speed vaccine deployment to AI-powered process control, what separates hype from real manufacturing transformation? The biotech industry faces a fundamental challenge: how do you maintain rigorous quality standards while accelerating development timelines, personalizing therapies, and adopting transformative technologies? The answer isn't found in chasing every innovation trend, it's in understanding which changes create genuine value and when to implement them across the produc...
The biotech industry operates under constant tension: we work with products that directly impact human lives, demanding rigorous controls and validation at every step. Yet standing still means falling behind. The question isn't whether to innovate, it's how to do it without compromising the quality and safety standards that define our industry. Irina Ramos has lived this paradox throughout her career. As a downstream processing leader who's guided CMC programs from early development through g...
What if you could analyze every metabolite, glycan variant, and unknown impurity in your bioprocess sample—not just the targets you're looking for, but everything that's actually there? Cryogenic infrared ion spectroscopy combined (CIRIS) with AI-powered analysis transforms untargeted screening from aspiration to reality. This episode moves from fundamental principles to practical applications. While Part 1 established how CIRIS overcomes mass spectrometry's structural limitations, Part 2 rev...
What if you could identify every structural variant in your biologics—without ambiguity, without massive sample requirements, and without the guesswork that plagues traditional mass spectrometry? Cryogenic infrared ion spectroscopy (CIRIS) makes it possible, transforming molecular characterization from frustrating puzzle to precise science. Today's guest, Professor Tom Rizzo, bridges the gap between academic innovation and industrial application. As former Dean of the School of Basic Sciences...
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 really drives emissions and how small process tweaks can deliver big results. Niklas goes beyond the numbers, challenging assumptions and showing how ...
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 framework that reveals exactly where your money goes and why. In this episode of the Smart Biotech Scientist Podcast, David Brühlmann talks with Niklas Ju...
Cell and gene therapies are transforming modern medicine, but their path to market is fast and complex. They often jump from small trials to global launch at record speed, putting pressure on analytics, supply chains, and partnerships. Success depends on making smart choices about what to build in-house and what to entrust to expert partners. Daniel Galbraith knows these challenges intimately. With decades of hands-on experience and as Chief Scientific Officer at Solvias, Daniel has witnessed...
Finding an analytical CRO that's truly invested in your success, not just processing samples, makes all the difference in CMC development. In this episode, host David Brühlmann talks with Daniel Galbraith, Chief Scientific Officer at Solvias, about the essential questions and mindset that lead to breakthrough CRO partnerships. With nearly three decades in analytical development, spanning monoclonal antibodies, biosimilars, and cell and gene therapies, Daniel reveals what separates CROs who be...
What if the answer to battling antibiotic-resistant infections isn’t a new antibiotic, but harnessing viruses that have been quietly dominating bacterial populations? Bacteriophages, viruses that target and kill bacteria, have been saving lives for a century, but their true potential is only now being unlocked by modern machine learning. The race isn’t just about discovering effective phages; it’s about deploying the right therapy, personalized to the patient, before time runs out. On this ep...
Antibiotic resistance isn’t just a looming problem. It’s a global crisis. Every year, more than one million people die directly from resistant infections, and another 5 million die indirectly. Routine infections are becoming life-threatening, and healthcare systems worldwide are under pressure. Despite decades of warnings, pharmaceutical solutions are falling behind, while “superbugs” continue to outpace new drug development. If trends continue, by 2050, antibiotic resistance could claim 10 m...
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 ...
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 exper...
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 si...
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 h...
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