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
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Jan 9, 2025 • 15min

118: Cell Line Development Secrets: Eliminating Critical Bottlenecks for Faster Timelines with Andrea Gough - Part 2

In the second part of our conversation with Andrea Gough, Senior Director for Advanced Instruments’ Solentim Portfolio, we’ll explore how AI and machine learning have, in recent years, begun to transform various aspects of biotechnology, including cell line development (CLD). Andrea shares insights into how these cutting-edge technologies are being applied to the early stages of clone selection.AI's capability to analyze images and classify clone viability is another breakthrough. Feeding thousands of images into AI systems allows for efficient and accurate decision-making, reducing the workload on scientists.Here are three key takeaways from our conversation:Leverage AI and Machine Learning: Integrate AI to streamline clone selection and optimize cell line development processes. AI can identify key phenotypic identifiers and predict the best clones, driving efficiency and productivity.Diversify Expression Systems: While CHO cells dominate the protein therapy space, exploring alternative systems like HEK cells, MSCs, IPSCs, and even insect cells can offer unique benefits and improve gene therapy productions.Maintain Comprehensive Documentation: Ensure rigorous tracking and documentation of all processes. From certificates of analysis to raw image data, having meticulous records will safeguard your development process and aid compliance with regulatory standards.Tune in to the full episode for more insights on overcoming challenges in cell line development and tips for setting up successful bioprocessing workflows!Connect with Andrea GoughLinkedIn: www.linkedin.com/in/andrea-gough-72915282Advanced Instruments: www.aicompanies.comNext 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 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6tSupport the show
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Jan 7, 2025 • 25min

117: Cell Line Development Secrets: Eliminating Critical Bottlenecks for Faster Timelines with Andrea Gough - Part 1

Cell line development (CLD) is a cornerstone of biologics production. This intricate process involves establishing a cell line capable of consistently producing a desired product, such as a therapeutic protein. While advancing science has refined numerous aspects of CLD, bottlenecks still exist, perpetuating challenges for scientists and industry professionals.In this episode of the Smart Biotech Scientist Podcast, Andrea Gough, Senior Director for Advanced Instruments’ Solentim Portfolio, shared her extensive insights into the critical bottlenecks and innovative breakthroughs in cell line development.Here are three key takeaways from this episode:Understanding the DNA Integration Complexity: Andrea discusses the pros and cons of random integration, highlighting how it can become a bottleneck. She emphasizes the importance of choosing the right methodology from the very beginning to avoid the "needle in a haystack" scenario when searching for a good clone.Modern Tools for Ensuring Clonality: Technologies like imaging devices and single-cell dispensers have revolutionized the process. Learn about the shift from traditional limiting dilution methods to more sophisticated and efficient tools that provide better evidence for regulatory approval.Innovative Approaches to Accelerate Development: Discover how semi-targeted integration methods like transposon technology can significantly shorten timelines and improve clone stability. Andrea also explores the use of bulk pools to generate initial products quickly for pre-clinical and initial clinical studies.Developing cell lines is a complex process, but with advanced tools and innovative approaches, challenges can become opportunities. As biotechnology progresses, the ability to stay informed and flexible will remain essential for success.Catch the full episode to gain deeper insights and practical advice for advancing your cell line development projects!Join us for the next episode featuring Andrea Gough, as we explore how AI and machine learning are being integrated into the early stages of clone selection. This groundbreaking approach is transforming key areas of biotechnology, including cell line development (CLD).Connect with Andrea Gough:LinkedIn: www.linkedin.com/in/andrea-gough-72915282Advanced Instruments: www.aicompanies.comNext 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 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show
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Dec 19, 2024 • 17min

116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy Agresti - Part 2

The intersection of artificial intelligence and biology presents immense opportunities for transforming bioprocess development. As the biotech industry continues to evolve, data-driven innovations are critical to optimizing biologics manufacturing. High-quality datasets stand at the forefront of this transformation, empowering researchers to make informed predictions and advance therapeutic discoveries. As AI tools become more commoditized, the focus shifts toward generating robust and extensive datasets to maximize the potential of machine learning in biological applications.Miniaturization has emerged as a vital enabler in this data-driven approach. Miniaturized systems allow researchers to conduct thousands of tests in an area no larger than the palm of your hand. This drastic reduction in material and resource requirements makes high-throughput screening feasible, economical, and scalable.Traditional liquid handling robots can manage thousands of tests per day, but each test requires considerable amounts of material, usually leading to high costs. Conventional systems can cost anywhere from $10 to $100 to get a single genotype sequence from discovery to sequencing. Miniaturization can bring these costs down to mere pennies per data point, making it possible to scale the dataset size exponentially.Key takeaways from our discussion:The future of AI in biology relies heavily on large, well-annotated datasets. Without them, the full potential of AI remains untapped. High-quality data enables more accurate predictions of protein structures and functions.Success in bioprocess development often involves collaboration with partners across the value chain. By working together, companies can leverage their unique strengths and expertise to overcome barriers and innovate more efficiently.Advancements in miniaturization technology allow for high throughput screening at reduced costs. This shift makes it viable to generate large datasets, speeding up the pace of discovery and making AI-driven predictions more accessible.This episode is essential for anyone eager to explore the transformative fusion of AI and biotechnology. Jeremy Agresti highlights the future of bioprocessing at the intersection of high-throughput screening, miniaturization, and AI, revealing how these innovations are solving complex challenges, driving breakthroughs, and shaping the future of science and medicine.Connect with Jeremy Agresti:LinkedIn: www.linkedin.com/in/jeremy-agresti-88546850/Triplebar: www.triplebar.comNext Steps:Overwhelmed by complex bioprocess development decisions? Get strategic guidance to avoid costly mistakes and stay ahead: https://bruehlmann-consulting.comAre soaring manufacturing costs keeping your lifesaving therapies out of reach for patients? Book your free assessment at: https://bruehlmann-consulting.com/assessmentSupport the show
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Dec 17, 2024 • 20min

115: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy Agresti - Part 1

Bioprocess 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. With tools that enhance predictability, scalability, and efficiency, Triplebar is set to transform biotechnology. By reimagining traditional methods, improving inputs, and leveraging modern technology, companies like Triplebar are driving a new era in bioprocessing, offering innovative solutions to complex biological challenges.Key Takeaways:Jeremy challenges the traditional view of scale-up issues, emphasizing that many problems can be solved at a smaller scale with better engineered strains and cell lines.By creating tiny bioreactors of droplets, Triplebar is able to perform high throughput screening, testing millions of mutations quickly and efficiently, and providing robust solutions for complex biological functions.The integration of massive data sets with AI allows for improved enzyme and protein design, unlocking the potential to innovate even when foundational understanding is limited.Ready to dive deeper? Join the journey of transforming bioprocess development with smart insights and pioneering spirit. Catch up with Jeremy’s full story via the latest episode of the Smart Biotech Scientist podcast.Connect with Jeremy Agresti:LinkedIn: www.linkedin.com/in/jeremy-agresti-88546850/Triplebar: www.triplebar.comNext Steps:Overwhelmed by complex bioprocess development decisions? Get strategic guidance to avoid costly mistakes and stay ahead: https://bruehlmann-consulting.comAre soaring manufacturing costs keeping your lifesaving therapies out of reach for patients? Book your free assessment at: https://bruehlmann-consulting.com/assessmentSupport the show
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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
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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
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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. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show
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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
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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
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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

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