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

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
Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
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5 de 163
  • 162: How to Achieve 85%+ Cell Recovery Without DMSO's Toxic Side Effects with Jeffrey Allen - Part 2
    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 extensive C-level and international experience in the life sciences sector, Jeffrey has a proven track record of transforming performance and delivering profitable growth in various market environments.Here are three key takeaways for anyone passionate about advancing biotech:The four-step audit: bridging best practices and real-world results: Depending on client needs, the audit is performed either at the client’s laboratory or at Evia Bio’s own facility, ensuring real-world practices are scrutinized and optimized.Protocols matter and so does execution: Even the best-written protocols can falter if not followed meticulously. Regular process audits, sometimes conducted onsite by external partners, help identify “protocol creep” and ensure teams are consistently implementing best practices.Culture fuels innovation: Jeffrey’s leadership advice resonated-aligning on strategy, fostering unified company culture, and surrounding yourself with talented people accelerates growth. Passion for the mission, combined with a strong, diverse team, can deliver both exceptional results and lasting employee engagement.Curious how these insights could save you months of frustration and millions in development costs? Tune in to the full episode, or get in touch to discuss how process optimization can empower your cell therapy journey!Connect with Jeffrey Allen:LinkedIn: www.linkedin.com/in/jeffreydallen2Website: www.eviabio.comEmail: [email protected] step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/Support the show
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  • 161: How to Achieve 85%+ Cell Recovery Without DMSO's Toxic Side Effects with Jeffrey Allen - Part 1
    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.Inspired by the survival strategies of Minnesota’s frozen forests, a new wave of biotech innovation is transforming the way we freeze, store, and ship life-saving cells for therapies - and it all starts with a better understanding of nature.Here are the top three takeaways from this podcast episode:Cryopreservation shouldn’t be an afterthought: Building optimal cryopreservation strategies into your process development from day one can avoid costly setbacks and delays.Beyond cell viability - function matters: It’s not just about how many cells survive the freeze/thaw cycle, but whether those cells remain fully functional. Evia Bio’s new DMSO-free formulations are delivering >85% recovery on MSCs without compromising cell function.One size doesn't fit all: Every cell type has unique needs for freezing, thawing, and formulation. Leveraging tailored algorithms and customized protocols can drastically improve yield and reproducibility, potentially reducing the need for costly overfilling in manufacturing.If you’ve ever lost precious cell samples to a freeze-thaw mishap or questioned why you’re stuck with outdated, toxic cryopreservation methods, this episode is for you!Connect with Jeffrey Allen:LinkedIn: www.linkedin.com/in/jeffreydallen2Website: www.eviabio.comEmail: [email protected] step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/Support the show
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  • 160: The Ultimate Guide to Accelerating Perfusion Process Development Using 96-Deep-Well Plates with Tom Valentin - Part 2
    In this concluding episode of our deep dive into miniaturized perfusion systems, we tackle the most challenging aspect: implementing meaningful process analytical technology (PAT) at microscale while keeping costs realistic for high-throughput applications.Tom Valentin, group leader at CSEM for Automated Sample Handling, continues sharing CSEM's pioneering work in automated sample handling, revealing both the breakthrough opportunities and stubborn technical barriers that define the current state of small-scale perfusion development.Critical insights you'll gain from this episode:The PAT miniaturization challenge is about more than size: While optical density sensors work reasonably well for microbial cultures, mammalian cell applications demand more sophisticated solutions. Tom explains why viable cell density remains the "holy grail"—and how promising technologies from companies like IMEC and Inspec are pushing the boundaries, though cost-effective 96-well implementation remains elusiveSmart compromises can unlock practical solutions: Tom reveals why the industry may need to accept hybrid approaches—real-time pH and DO monitoring combined with once-daily viable cell density sampling. He also explains the unique challenges of sensor positioning in shaking deep-well plates where liquid dynamics create measurement complexitiesPartnership models that actually work for biotech innovation: Beyond the technical discussion, Tom outlines CSEM's proven collaboration approaches, including how Innoswiss funding can provide 50% cost reduction for development projects and why their 70% proposal success rate makes them an attractive R&D partner for both startups and established pharma companiesDiscover how bioprocessing is evolving - from high-throughput screening to digital twins and continuous manufacturing- in these expert-led episodes.Episode 155: From Process Bottlenecks to Seamless Production: How Continuous Bioprocessing Changes EverythingEpisodes 153-154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago MatosEpisodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo MorbidelliEpisodes 73-74: Bead-Based Assays: The Power of High-Throughput Screening with Sebastian GiehringConnect with Tom Valentin:LinkedIn: www.linkedin.com/in/tom-valentin-5bb9091bWebsite: www.csem.ch/enEmail: [email protected] step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/Support the show
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  • 159: The Ultimate Guide to Accelerating Perfusion Process Development Using 96-Deep-Well Plates with Tom Valentin - Part 1
    In bioprocess development, the ability to rapidly screen conditions and predict scale-up performance can mean the difference between a successful therapy launch and costly delays. Today's Smart Biotech Scientist episode features Tom Valentin from CSEM, who's pioneering revolutionary approaches to miniaturized perfusion systems that could transform how we develop biologics.Tom is a group leader at CSEM for Automated Sample Handling within the Life Sciences and Industry 4.0 business unit. As a mechanical and biomedical engineer, he brings a unique cross-disciplinary perspective to solving bioprocessing's most challenging miniaturization problems.What makes this conversation essential listening:96-deep-well plates are revolutionizing perfusion development: Tom reveals how CSEM's innovative fluidic lids enable continuous medium exchange in 300-microliter volumes, potentially allowing up to 96 parallel perfusion experiments with automated liquid handlers and shaker incubatorsThree critical barriers still need solving: Despite the promise, Tom identifies the key technical challenges that must be overcome: ultra-low flow rate liquid handling (imagine exchanging 300 μL over 24 hours), effective cell retention in miniaturized systems, and cost-effective real-time biomonitoring that fits within well plate constraintsThe future of process development is automated and intelligent: From pressure-over-liquid systems to advanced sensor integration, Tom outlines how companies can achieve near-autonomous perfusion screening—but warns that current sensing limitations mean viable cell density monitoring remains the "holy grail" of small-scale perfusionThis isn't just about smaller equipment—it's about fundamentally changing how we approach process development. If you're working in cell culture optimization, process scale-up, or bioprocess automation, Tom's insights reveal both the tremendous opportunities and practical realities of implementing next-generation perfusion systems.For biotech professionals, staying ahead means embracing these high-throughput, data-rich models, allowing smarter, faster, and more predictive process development for the therapies of tomorrow.Discover how bioprocessing is evolving - from high-throughput screening to digital twins and continuous manufacturing- in these expert-led episodes.Episode 155: From Process Bottlenecks to Seamless Production: How Continuous Bioprocessing Changes EverythingEpisodes 153-154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago MatosEpisodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo MorbidelliEpisodes 73-74: Bead-Based Assays: The Power of High-Throughput Screening with Sebastian GiehringConnect with Tom Valentin:LinkedIn: www.linkedin.com/in/tom-valentin-5bb9091bWebsite: www.csem.ch/enEmail: [email protected] step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/Support the show
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  • 158: How to Detect Endotoxins Without Bleeding a Single Horseshoe Crab with Anika Hoffmann - Part 2
    In this concluding episode of our series on revolutionary endotoxin detection, we continue our conversation with Anika Hoffmann about transitioning from theory to practice in the quest for more reliable, sustainable testing methods. Anika is a postdoctoral researcher in analytical chemistry at HES-SO Valais-Wallis, Switzerland.Having established why traditional LAL testing falls short in Part 1, we now explore how Anika's innovative KDO-based chemical analytical approach compares in real-world applications:Greater accuracy you can trust: The new method delivers impressive 5-10% coefficient variation (compared to LAL's 25%), works across broader pH and formulation conditions, but is still working toward the sensitivity targets needed for all pharmaceutical applicationsClear path to regulatory acceptance: Anika outlines how companies can validate alternative methods against established standards like LAL, recombinant Factor C, or monocyte activation tests to gain approval from authoritiesSustainable testing strategy: Health authorities and customers are increasingly demanding sustainable alternatives as horseshoe crab populations decline while testing demand rises—adopt ethical, animal-free methods now before they become an industry requirementMost excitingly, Anika reveals her entrepreneurial journey from accidental discovery to startup founder. Her passion for solving this critical industry challenge exemplifies how scientists can transform technical innovations into practical solutions that benefit both industry and the environment.Whether you're a bioprocess scientist struggling with endotoxin testing, a quality assurance professional seeking more reliable methods, or someone interested in sustainable alternatives to animal-based testing, this episode provides a clear path toward a future where patient safety doesn't rely on horseshoe crab blood.Listen now to discover how you can implement smarter endotoxin testing at your organization – and reach out to Anika via the links in our show notes if you want to be among the first to access this groundbreaking technology.Connect with Anika Hoffmann:LinkedIn: www.linkedin.com/in/anika-hoffmann-652ab0196/Email: [email protected] step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/Support the show
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Acerca de Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

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/callFast-track bioprocess development with expert guidance: https://bruehlmann-consulting.comVisit the Website: https://smartbiotechscientist.comEmail us: [email protected]
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