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

• 180: How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davis - Part 2

  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 clinical barriers.Lindsay Davies is a leading figure in the cell and gene therapy field, serving as Vice President-Elect for Europe at the International Society of Cell and Gene Therapy (ISCT). She is Chief Scientific Officer at NextCell Pharma, co-founder of QVance, and founder of the consultancy CellTherEx. With over 20 years of experience across academia and industry, she brings deep expertise in MSC manufacturing, process development, and commercialization of advanced therapies. Here are three reasons this episode is a must-listen:Manufacturing at Scale, Without Compromise: Lindsay shares why NextCell Pharma has stuck with large-scale 2D manufacturing for MSCs, leveraging cell morphology and a patented donor selection algorithm to reduce batch-to-batch variability while maximizing reproducibility and safety, even when treating hundreds from a single batch.Smart Scaling: Up, Out, or Both? The debate isn’t just academic. Lindsay explores when it makes sense to scale up processes versus scaling out to multiple manufacturing sites. She highlights how harmonizing global regulatory expectations and moving to closed 2D systems can lower costs, de-risk production, and bring life-changing therapies to more patients worldwide.Network or Nowhere: Lindsay calls out the myth of the lone innovator, championing the crucial role of strategic networking, partnership models, including “sweat equity”, and early regulatory engagement as keys to avoiding the common commercialization pitfalls that stall so many promising ATMPs.Wondering how to navigate the twin challenges of process control and commercial viability in ATMP development? This episode offers a rare, candid roadmap from the front lines.Connect with Lindsay Davis:LinkedIn: www.linkedin.com/in/lindsay-c-daviesWebsite: www.nextcellpharma.comIf you're interested in breakthroughs in cell therapy, here's what some of our previous guests have shared from the front lines of innovation:Episodes 105-106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 109-110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier DetournayEpisodes 125-126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon ShareiNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call🧬 Ready to eliminate CMC chaos and hit your IND timeline with absolute certainty? Get the complete Notion CMC Dashboard at https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders - the proven roadmap that's guided successful mAb programs to hit their IND submission deadlines.Join 500+ CGT leaders at Advanced Therapies Europe 2025 (September 2-4, Barcelona) for live case studies, regulatory insights, and exclusive collaboration opportunities. As a Smart Biotech Scientist listener, you’ll save 20% with code SMARTPODCAST20 – Register hereSupport the show

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• 179: How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davies - Part 1

  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 molecule by molecule - instead, they orchestrate an anti-inflammatory response, offering new hope for conditions once considered incurable.In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann speaks with Lindsay Davies, a leading expert in advanced therapies. She is the CSO at NextCell Pharma, consultant at CellTherEx, and co-founder of QVance, a QC analytics provider for ATMPs. Recently elected Vice President Elect for Europe at ISCT, Lindsay also chairs its European Industry Committee and serves on multiple task forces. With over 20 years bridging academia and industry, she’s helped shape the full lifecycle of cell-based therapies, from development to commercialization.Here are three reasons why you can’t miss this episode:Stromal Cells - The Unsung Heroes: Discover the essential distinction between stem cells (the “builders”) and stromal cells (the “coordinators”), and how harnessing the latter’s unique immune-modulatory powers is unlocking treatments for diabetes, COVID-19, and autoimmune diseases.A Manufacturing Mindset Shift: Lindsay explains why scaling out cell therapies defies the “plug-and-play” approaches of traditional biologics manufacturing. With cell quality so sensitive to environmental shifts, the key lies in process simplicity, early regulatory collaboration, and deep biological understanding - especially when donor variability enters the mix.Allogeneic Therapies Made Real: Thanks to umbilical cord-derived stromal cells, treatments can be manufactured at scale, stored frozen, and delivered on demand - no patient matching required. The result? Outpatient infusions, no side effects, and effects lasting up to five years, dramatically simplifying lives for those with chronic inflammatory conditions.Ready to rethink how cell therapies are changing medicine - and what it could mean for your bioprocessing strategy? Hit play and find out how Lindsay Davis is redefining what’s possible in advanced therapy manufacturing.Connect with Lindsay Davis:LinkedIn: www.linkedin.com/in/lindsay-c-daviesWebsite: www.nextcellpharma.comIf you're interested in breakthroughs in cell therapy, here's what some of our previous guests have shared from the front lines of innovation:Episodes 105-106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 109-110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier DetournayEpisodes 125-126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon ShareiNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call🧬 Ready to eliminate CMC chaos and hit your IND timeline with absolute certainty? Get the complete Notion CMC Dashboard Join 500+ CGT leaders at Advanced Therapies Europe 2025 (September 2-4, Barcelona) for live case studies, regulatory insights, and exclusive collaboration opportunities. As a Smart Biotech Scientist listener, you’ll save 20% with code SMARTPODCAST20 – Register hereSupport the show

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• 178: Rethinking Cultivated Meat Production: Scale and Media Optimization Strategies Slashing Manufacturing Costs with Richard Alldread - Part 2

  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 production realities?In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann sits down with Richard Alldread, CTO of The Cultured Hub - a unique joint venture between Givaudan, Bühler, and Migros - positioned at the intersection of flavor, food processing, and retail expertise.Richard Alldread has led process and technology development across the biopharmaceutical sector, with roles at major biotech corporations and brings decades of experience from the biopharma world into the food tech sphere, helping innovative startups bridge the gap from promising lab results to economically and technically scalable food products.Here are three reasons to keep listening:Scaling Up, Not Just Out: Richard exposes why many food startups stumble: overly complex, non-scalable processes and the misapplication of biopharma’s single-use equipment. Instead, the food industry is reigniting interest in robust stainless steel facilities to meet the vastly greater scale and lower margins of food versus pharma.From Bench to Market: The Cultured Hub isn’t just about tanks and tech; it’s a one-stop shop where startups gain hands-on access to commercial-scale bioreactors, regulatory expertise, and direct links to the whole value chain, from flavor development to supermarket shelves.Consumer Acceptance Is (Still) King: No matter how flawless the process or affordable the meat, Richard emphasizes that success hinges on consumer adoption. The industry’s greatest test isn’t technological, it’s shifting perceptions of cultured foods to turn curiosity into routine repeat purchases.Ready to hear what it really takes to transition cultured food from niche curiosity to supermarket staple? Dive into this episode and discover the hard truths, emerging solutions, and industry insights driving the next food revolution.Connect with Richard Alldread:LinkedIn: www.linkedin.com/in/richard-alldread-01923644Website: www.theculturedhub.comWant to hear more perspectives on the future of cell-based food? Don’t miss these previous episodes:Episodes 55-56: Cultivated Meat: A Promising Future or an Inevitable Bubble? with Steven LangEpisodes 45-46: From Lab to Table: The Science Behind Cultivated Meat with Petra HangaEpisodes 15-16: Bacon Without Pigs? Innovations in Cultivated Meat Manufacturing with Beat ThalmannNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call🧬 Ready to eliminate CMC chaos and hit your IND timeline with absolute certainty? Get the complete Notion CMC Dashboard at https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders - the proven CMC roadmap for IND submission.Join 500+ CGT leaders at Advanced Therapies Europe 2025 (September 2-4, Barcelona) for live case studies, regulatory insights, and exclusive collaboration opportunities. As a Smart Biotech Scientist listener, you’ll save 20% with code SMARTPODCAST20 – Register hereSupport the show

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• 177: Rethinking Cultivated Meat Production: Scale and Media Optimization Strategies Slashing Manufacturing Costs with Richard Alldread - Part 1

  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 sustainable, affordable protein for the masses, innovators are confronting a challenge bigger than scale.This week, host David Brühlmann welcomes Richard Alldread, Chief Technology Officer at The Cultured Hub, a groundbreaking joint venture between three Swiss industry leaders that specializes in developing and scaling cell culture processes for cultivated foods.Most of Richard’s career has been dedicated to leading process and technology development initiatives within the biopharmaceutical industry. He has held key roles at major biotech organizations. He now leads the charge in applying high-tech bioprocessing to the ultimate scale-up: cultivated food. His journey from pioneering life-saving biologics to reimagining food production offers a rare insider’s view of biotech’s next frontier.Here are three reasons you can’t miss this episode:Bioprocessing’s Universal Blueprint: Richard breaks down the striking similarities between pharmaceuticals and food - media, bioreactors, sterility - but reveals why the economics and scale make cultivated food an entirely new beast.From Clinic to Kitchen: Discover how the shift from producing grams of life-saving drugs for the West to tons of affordable protein for global tables flips traditional priorities, pushing innovation in cost reduction, media development, and facility design.The Art of Keeping it Simple: Richard shares a contrarian philosophy: the best processes need fewer high-tech analytics, not more. He weighs in on where digital tools, modeling, and even AI fit into building robust, scalable bioprocesses for the food industry.Curious about how the lessons of biopharma might feed the world? Dive into this episode to uncover the biggest technical, economic, and biological hurdles - and why the next big leap in bioprocessing may end up on our dinner plates.Connect with Richard Alldread:LinkedIn: www.linkedin.com/in/richard-alldread-01923644Website: www.theculturedhub.comWant to hear more perspectives on the future of cell-based food? Don’t miss these previous episodes:Episodes 55-56: Cultivated Meat: A Promising Future or an Inevitable Bubble? with Steven LangEpisodes 45-46: From Lab to Table: The Science Behind Cultivated Meat with Petra HangaEpisodes 15-16: Bacon Without Pigs? Innovations in Cultivated Meat Manufacturing with Beat ThalmannNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call🧬 Ready to eliminate CMC chaos and hit your IND timeline with absolute certainty? Get the complete Notion CMC Dashboard at https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders - the proven CMC roadmap for IND submission.Join 500+ CGT leaders at Advanced Therapies Europe 2025 (September 2-4, Barcelona) for live case studies, regulatory insights, and exclusive collaboration opportunities. As a Smart Biotech Scientist listener, you’ll save 20% with code SMARTPODCAST20 – Register hereSupport the show

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• 176: How Virtual Reality Training Solves Europe's Bioproduction Talent Shortage with Sandrine Lemoine - Part 2

  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 empowered with both technical expertise and the soft skills necessary to thrive.In this episode, host David Brühlmann explores the human side of bioproduction with Sandrine Lemoine, CEO of Immerscio.bio, who has dedicated her career to transforming talent development in the industry. Sandrine Lemoine brings a unique perspective to biotech training: as both an executive coach and a veteran of pharmaceutical leadership roles, she founded Immerscio.bio to bridge the gap between innovation and workforce development. Her work focuses on immersive, flexible training that prepares biotech professionals - new and experienced alike - for the evolving demands of modern bioproduction, keeping Europe’s talent future-ready.Here are three reasons why you shouldn’t miss this episode:Soft Skills as a Catalyst: Sandrine reveals why leadership, collaboration, and a “co-construction” approach are critical to effective innovation in bioproduction, not just as buzzwords, but as real drivers of successful project delivery.Continuous Learning as a Strategy: Discover how Immerscio.bio’s adaptable training modules keep professionals ahead of the curve in a field defined by fast regulatory shifts, automation, and new therapies - arming teams for every transition, from immunology pivots to advanced manufacturing technologies.Resilience through Workforce Development: As Europe faces unprecedented talent shortages and global competition, Sandrine explains how investing in people and fostering a habit of lifelong learning is key to healthcare sovereignty and the industrialization of scientific progress.Ready to upgrade your own bioprocessing career or build a future-ready team? This conversation will inspire you to see training not as a checkbox, but as your greatest tool for impact in biotech.Connect with Sandrine Lemoine:LinkedIn: www.linkedin.com/in/sandrine-lemoine-ba244a58Website: https://immerscio.bioNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing development and manufacturing: 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 https://stan.store/SmartBiotechSupport the show

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