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
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 clarityExcel at scale-up and manufacturing of biologicsTransform your innovative therapy and manufacturing technology into market-ready solutions fasterOptimize manufacturing costs without compromising qualityMake data-driven decisions that reduce the risk of failureI 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-foundersAccelerate biologics development with expert guidance: https://bruehlmann-consulting.comVisit the Website: https://smartbiotechscientist.comEmail us: hello@bruehlmann-consulting.com
Episodes
Mentioned books
Dec 12, 2024 • 18min
114: Weighing of Single-Use Bag Systems: Why Traditional Load Cells Are Holding You Back with Anders Tvegaard - Part 2
Is your bioprocess facility wasting precious time and resources on traditional weighing system calibrations? In this eye-opening episode, Anders Tvegaard, COO of Eilersen Electric, reveals how digital load cell innovation is revolutionizing bioprocess monitoring and validation.Discover why weighing systems aren't the commodity technology you might think they are, and how choosing the right solution can dramatically reduce deviations and maintenance costs. Anders shares groundbreaking insights about Eilersen's water-free calibration system, which has helped customers save over a million liters of water and 700 man-hours in tank calibration time.Key takeaways:Why a single weighing system deviation can cost facilities $10,000+ in quality management aloneHow new digital load cell technology enables continuous monitoring during mobile vessel transportThe game-changing advantages of water-free calibration for single-use systemsReady to transform your bioprocess monitoring strategy? Listen now to learn how modern weighing technology can protect your products and streamline your operations.Connect with Anders Tvegaard:LinkedIn: https://www.linkedin.com/in/anders-tvegaard-3305a1Eilerson: https://eilersen.comNext Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Learn more at https://bruehlmann-consulting.comSupport the show
Dec 10, 2024 • 22min
113: Weighing of Single-Use Bag Systems: Why Traditional Load Cells Are Holding You Back with Anders Tvegaard - Part 1
What do furniture manufacturing and bioprocess weighing have in common? In this fascinating episode, Anders Tvegaard, COO of Eilersen Electric Digital Systems shares the remarkable story of how his company evolved from solving a furniture maker's wood humidity measurement problems to revolutionizing pharmaceutical manufacturing.Fifty years ago, a simple request to build a more robust scale for weighing wood in sofa production led to the development of groundbreaking contactless load cell technology.Key takeaways for bioprocess professionals:Discover how a furniture problem sparked innovation in bioprocess weighing technologyLearn why traditional strain gauge technology may be compromising your mobile vessel operationsUnderstand how contactless load cells eliminate costly calibration deviations and production stopsFrom humble beginnings in a Danish basement to transforming modern bioprocessing, this episode reveals how cross-industry innovation is reshaping pharmaceutical manufacturing. Whether you're managing mixing tanks, mobile vessels, or single-use systems, you'll gain valuable insights into improving your bioprocess reliability.Ready to discover how furniture-inspired technology is solving today's bioprocessing challenges? Tune in now.Connect with Anders Tvegaard:LinkedIn: https://www.linkedin.com/in/anders-tvegaard-3305a1Eilerson: https://eilersen.comNext Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Learn more at https://bruehlmann-consulting.comSupport the show
Dec 5, 2024 • 25min
112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars Brandén - Part 2
Can artificial intelligence revolutionize drug development and reduce the staggering 90% failure rate in clinical trials? In this insightful episode, Lars Brandén, Director of Biology at Kolibri, shares his vision for the future of personalized medicine.Drawing from his extensive experience bridging academia and industry, Lars explores how AI models could transform our understanding of human disease by simulating body-wide cell signaling. He reveals an innovative approach to drug delivery using receptor ligand combinations that could dramatically reduce side effects and improve treatment efficacy.Key takeaways:Learn why maintaining "youthful naivety" in biotech innovation can lead to breakthroughs others deemed impossibleDiscover how combining AI with deep biological understanding could reduce clinical trial failure rates from 90% to potentially 15%Understand why interdisciplinary collaboration between biologists, software engineers, and other experts is crucial for advancing personalized medicineReady to dive deeper into the future of biotech innovation? Listen now to unlock Lars Brandén's insights on scaling therapies, navigating cross-functional teams, and maintaining scientific creativity in the face of challenges.Connect with Lars Brandén:LinkedIn: https://www.linkedin.com/in/larsbrandenNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com🧬 Stop second-guessing your CMC strategy before investor meetings. Our 1-Week CMC Assessment reveals your roadmap gaps and transforms uncertain founders into confident presenters who ace investor meetings. Secure your assessment at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-readySupport the show
Dec 3, 2024 • 19min
111: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars Brandén - Part 1
In this episode, we explore the delicate dance between artificial intelligence and biological research with Lars Brandén, Director of Biology at Kolibri. From his early fascination with gene therapy to pioneering high-throughput screening centers at prestigious institutions, Lars shares invaluable insights on bridging the gap between academic innovation and industrial application.What sets this conversation apart is Lars' compelling perspective on why the popular "agile development" model doesn't always translate smoothly to bioprocess development – and why that matters for the future of drug development. His journey from the Karolinska Institute to leading cutting-edge biological research offers a unique lens on the evolution of biotech.Key takeaways for listeners:Learn why scientists must develop broader cross-disciplinary knowledge to effectively leverage AI tools in researchDiscover how AI could dramatically reduce drug development timelines and costs within the next five yearsUnderstand the potential for AI to democratize access to cell and gene therapies through optimized production methodsJoin us for this fascinating exploration of how domain expertise and artificial intelligence can work in harmony to accelerate breakthrough therapies. Whether you're a biotech professional or simply curious about the future of medicine, this episode offers valuable insights into the transformation of drug development in the AI era.Listen now to discover how the intersection of human expertise and artificial intelligence is reshaping the future of personalized medicine.Connect with Lars Brandén:LinkedIn: https://www.linkedin.com/in/larsbrandenNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.comSupport the show
Nov 28, 2024 • 16min
110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier Detournay - Part 2
Could Earth's gentle movements hold the key to scaling up cell therapy production? In this fascinating episode, cellular biologist and entrepreneur Olivier Detournay (CSO of Cellura) reveals how his groundbreaking bioreactor design, inspired by geophysics, is transforming difficult cell culture processes.By mimicking natural planetary motions, his team at Celura has developed a low-shear stress bioreactor that elegantly solves common scale-up challenges.Key takeaways for biotech professionals:Discover how reducing rotational speed in larger volumes (from 70 RPM at 150ml to just 4 RPM at 200L) enables seamless scale-upLearn why simplifying bioreactor design leads to better control over shear stress and mixing qualityExplore how nature-inspired solutions could make cell therapy manufacturing more accessible and cost-effectiveWhether you're working in process development or manufacturing, this episode offers invaluable insights into the future of bioprocessing.Listen now to uncover how looking to nature might help solve your toughest scale-up challenges.Connect with Olivier Detournay:LinkedIn: https://www.linkedin.com/in/olivier-detournay-5b157417Cellura: https://cellura.ioNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO/CSO services. Curious? Learn more at https://bruehlmann-consulting.comSupport the show
Nov 26, 2024 • 19min
109: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier Detournay - Part 1
What if the secret to growing sensitive cells lies in mimicking Earth's own movement? In this fascinating episode, cellular biologist Olivier Detournay, CSO of Cellura, reveals how studying planetary motion led to a groundbreaking bioreactor design that could transform cell therapy manufacturing.Drawing inspiration from geophysics research on magma flows, Olivier and his colleagues developed a revolutionary impeller-free bioreactor that creates gentle, uniform mixing through precise rotation and tilt angles.Key takeaways for bioprocess scientists:Learn how natural planetary movements can inspire gentler cell cultivation methodsDiscover an innovative approach to scaling up sensitive cell production without shear stressUnderstand why traditional impeller-based systems may limit the future of bioprocessingWhether you're working with stem cells, immunotherapy, or cultivated meat, this episode offers fresh perspectives on overcoming bioprocessing challenges. Join us to explore how nature-inspired solutions could make life-saving cell therapies more accessible.Connect with Olivier Detournay:LinkedIn: https://www.linkedin.com/in/olivier-detournay-5b157417Cellura: https://cellura.ioNext Steps:Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO/CSO services. Curious? Learn more at https://bruehlmann-consulting.comSupport the show
Nov 21, 2024 • 28min
108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer - Part 2
In this captivating episode, we dive deep into the groundbreaking intersection of artificial intelligence and enzyme engineering with David Schönauer, founder and CEO of Aminoverse.From university lab benches to pioneering AI-driven enzyme discovery, David shares how his startup is transforming the biotech landscape by making enzyme development faster, more predictable, and increasingly efficient.Highlights:Discover how AI is revolutionizing enzyme prediction and design, potentially reducing development time from years to weeksLearn why high-quality wet lab data remains crucial for AI success in biotech, and how Aminoverse's unique approach combines both worldsGain insights into building a profitable biotech startup without massive venture capital funding, proving that sustainable growth is possible in deep techDavid's journey from academic researcher to biotech entrepreneur offers invaluable lessons for scientists considering the entrepreneurial path. His practical approach to combining cutting-edge AI with traditional wet lab techniques demonstrates how modern biotechnology can solve real-world problems while maintaining scientific rigor.Ready to explore the future of biotech? Listen now to learn how AI is transforming enzyme engineering and what it means for the future of sustainable technology, pharmaceuticals, and more.Connect with David Schönauer:LinkedIn: https://www.linkedin.com/in/david-schönauerAminoverse: https://www.aminoverse.comNext Steps:Wondering how to develop biologics with clarity and precision? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentReady to revolutionize your biologics development? Our Fractional CTO services help you develop better, faster, and more cost-effectively. Leverage your full potential today — book a free consultation at https://bruehlmann-consulting.com and let's accelerate your success!🧬 Stop second-guessing your CMC strategy before investor meetings. Our 1-Week CMC Assessment reveals your roadmap gaps and transforms uncertain founders into confident presenters who ace investor meetings. Secure your assessment at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-readySupport the show
Nov 19, 2024 • 19min
107: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer - Part 1
Ever 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 more than one billion enzyme sequences to identify the most promising candidatesLearn why the perfect balance between AI-powered screening and traditional lab testing is crucial for successful enzyme engineeringUnderstand how engineered enzymes are transforming industries, from mRNA vaccine production to eco-friendly laundry detergentsWhether you're a biotech professional or simply curious about the intersection of AI and biotechnology, this episode reveals how cutting-edge technology is accelerating the discovery of nature's molecular workers.Ready to explore the future of enzyme engineering? Tune in now to hear how AI is transforming biotech innovation, one enzyme at a time.Connect with David Schönauer:LinkedIn: https://www.linkedin.com/in/david-schönauerAminoverse: https://www.aminoverse.comNext Steps:Wondering how to develop biologics with clarity and precision? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentReady to revolutionize your biologics development? Our Fractional CTO services help you develop better, faster, and more cost-effectively. Leverage your full potential today — book a free consultation at https://bruehlmann-consulting.com and let's accelerate your success!Support the show
Nov 14, 2024 • 20min
106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver Kraemer - Part 2
In this insightful episode, Technical Development Leader at Flagship Pioneering Oliver Kraemer reveals why developing Advanced Therapy Medicinal Products (ATMPs) require a fundamental shift in thinking from traditional biologics development.Drawing from his extensive experience across Boehringer Ingelheim, Sanofi, and BMS, Kraemer challenges conventional wisdom about process development timing and demonstrates why early integration of process considerations is crucial for ATMP success.You will learn:Rethink Development Timing: Learn why incorporating process development earlier in ATMP programs dramatically reduces failure rates and prevents costly repetitionMaster Complexity: Understand the unique challenges of cell therapy development, including biological fitness and the critical interplay between cell lines, media, and processesNavigate Cost Implications: Discover strategies for managing the unexpectedly high development costs of ATMPs and making informed early decisions that impact commercial successReady to transform your approach to ATMP development? Join us for this must-listen episode as we demystify the path from bench to bedside in cell and gene therapy.Connect with Oliver Kraemer:LinkedIn: https://www.linkedin.com/in/oliver-kraemerNext Steps:Overwhelmed by complex CGT development decisions? Get strategic guidance to avoid costly mistakes and stay ahead: https://bruehlmann-consulting.comAre soaring manufacturing costs keeping your lifesaving cell and gene therapies out of reach for patients? Book your free assessment at: https://bruehlmann-consulting.com/assessmentSupport the show
Nov 12, 2024 • 22min
105: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver Kraemer - Part 1
In this eye-opening episode, we explore the intricate landscape of Advanced Therapy Medicinal Products (ATMPs) with Oliver Kraemer, a technical development leader at Flagship Pioneering.Drawing from his extensive experience at industry giants like BMS, Sanofi, and Boehringer Ingelheim, Oliver challenges conventional wisdom about automation in cell and gene therapy while illuminating the crucial differences between biologics and ATMPs.Key Takeaways for Biotech Scientists:Discover why automation isn't the ultimate solution for advancing CGT development right now, and what this means for your process development strategyLearn how ATMP development requires a fundamental rethinking of the traditional research-to-development pipelineUnderstand the critical early-stage decisions in cell therapy development that can make or break your project timelineJoin us as Oliver shares invaluable insights from his journey from traditional biologics to cutting-edge cell therapies, including both iPSC-derived and donor-derived approaches. Whether you're a bioprocess developer, cell therapy researcher, or biotech professional, this episode offers practical wisdom for navigating the complex landscape of ATMP development.Ready to transform your understanding of cell therapy development? Listen now to gain insights that could save you months or even years in your development timeline.Connect with Oliver Kraemer:LinkedIn: https://www.linkedin.com/in/oliver-kraemerNext Steps:Overwhelmed by complex CGT development decisions? Get strategic guidance to avoid costly mistakes and stay ahead: https://bruehlmann-consulting.comAre soaring manufacturing costs keeping your lifesaving cell and gene therapies out of reach for patients? Book your free assessment at: https://bruehlmann-consulting.com/assessmentSupport the show
