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

Ever feel like you’re drowning in an ocean of constantly shifting regulatory guidelines? The world of biotech is a whirlwind of evolving standards, making compliance not just a headache, but sometimes the stumbling block between life-changing therapies and the patients who need them. But what if artificial intelligence could turn regulatory chaos into your biggest competitive advantage?In this episode, David Brühlmann sits down with Abhijeet Satwekar, Innovation Manager at Merck KGaA’s Global Analytical Development. Abhijeet shares how he’s pioneering the use of generative AI, not as a hype machine, but as a practical, transformative tool for regulatory compliance in biotech. With over a decade navigating analytics, digitalization, and collaborative tech adoption at a major pharma leader, Abhijeet knows what it takes to connect industry stakeholders, harness new technologies, and turn business operations into streamlined, value-generating systems.Here are three reasons you won’t want to miss this episode:Generative AI as a Compliance Powerhouse: Discover how AI is being harnessed to analyze, extract, and compare complex regulatory requirements across different countries, cutting through ambiguous language and shifting specifications - so you don’t have to.Reducing Regulatory Bottlenecks: The days of manually reconciling guideline documents and updating baselines with every regulatory change are numbered. Learn how generative AI accelerates multi-guideline comparison, saving teams countless hours and reducing the risk of costly errors and delays.A Blueprint for Digital Transformation: Abhijeet reveals how Merck is moving from proof-of-concept to operational reality, building collaborative teams that bridge IT, analytics, regulatory, and quality to bring valuable digital tools into daily practice.Curious if your team could automate away regulatory headaches? Listen in and get inspired to tackle your toughest compliance challenges - before your competitors do.Connect with Abhijeet Satwekar:LinkedIn: https://www.linkedin.com/in/abhijeetsatwekarNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing development: 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/SmartBiotech🧬 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

Have you ever presented a major scientific breakthrough, only to be met with blank stares and distracted executives? You're not alone. In this episode, David Brühlmann shares how he went from drowning in data to winning an innovation contest, not through better tech, but through the power of scientific storytelling.Many scientists default to methods and data, but as David notes, “it’s like being fluent in a language nobody else in the room speaks.” Without a clear link to human impact, even the most brilliant work can go unnoticed.Key insights from the episode that could transform your next presentation:The Three-Act Structure: Storytelling That Resonates - David shows how Apple’s iPhone launch used this classic structure, and how scientists can do the same. Start with “why” (impact), then move to “how” (the science) to keep your audience engaged without losing rigor.Turning Your Audience Into the Hero: Adapting Donald Miller’s framework, David flips the script: your audience is the hero, and your innovation is their guide. It’s about speaking to their needs, not just showcasing your work.Why Storytelling Works: The Neuroscience Edge: Stories release dopamine (focus), oxytocin (trust), and endorphins (emotion) - activating how we naturally learn and remember. It’s not fluff; it’s brain science.Decision-makers won’t remember your chromatogram, but they will remember the story and its impact. The real test of your pitch? Whether it drives action: follow-up meetings or funding.You don’t need to simplify your science. You need to spotlight what matters most to your audience. With a strong narrative, your work stops being overlooked potential and starts becoming real-world impact.Ready to revolutionize your next presentation? Lean into the power of storytelling - your data, your career, and the lives you touch will thank you.Listen to the full episode to explore the straightforward storytelling structure David uses to bring scientific ideas to life.🔗 Book a free 20-minute consultation with Brühlmann Consulting to answer any questions you may have about how to craft a compelling scientific story that connects and inspires. https://bruehlmann-consulting.com/call/🔗 Turn Your Science into Funding Success. Book a 30-minute strategy session to transform your technical pitch into a compelling story that gets funded. Limited spots available. Schedule now at https://stan.store/SmartBiotech/p/turn-science-into-funding-a-pitch-that-sellsSupport the show

Have you ever poured months of research into a brilliant innovation, only to watch executives’ eyes glaze over during your presentation? You’re not alone. In this episode, host David Brühlmann describes a familiar frustration: scientists are trained to perfect data, not to sell ideas. But in today’s fast-paced biotech landscape, even the most groundbreaking technology risks fading into obscurity if it isn’t communicated effectively.Here’s what you’ll learn in this episode:Why Good Science Needs Great Storytelling: David Brühlmann shows that the most funded projects are often the best-communicated, because even experts remember stories, not raw data. A thrift-store experiment proves the point: stories can increase value by over 6,000%.Neuroscience: The Biology Behind the Narrative: Neuroscience shows that suspense, empathy, and humor trigger brain chemicals that boost attention, trust, and memory. That’s why even experts remember stories far more than data dumps.Bridging Science and Story, Without Sacrificing Integrity: Many scientists fear storytelling undermines rigor, but David argues the opposite: story is the map, data the landmarks. Emotion doesn’t weaken science, it makes it resonate and stick.Listen to the full episode to explore the straightforward storytelling structure David uses to bring scientific ideas to life.Don’t let your breakthrough ideas get buried in jargon and dense slides. Your science deserves to be heard—and you already have what it takes to tell a story that sticks. Need help with an upcoming presentation?🔗 Book a free 20-minute consultation with Brühlmann Consulting to answer any questions you may have about how to craft a compelling scientific story that connects and inspires. https://bruehlmann-consulting.com/call/🔗 Turn Your Science into Funding Success. Book a 30-minute strategy session to transform your technical pitch into a compelling story that gets funded. Limited spots available. Schedule now at https://stan.store/SmartBiotech/p/turn-science-into-funding-a-pitch-that-sellsSupport the show

From lab curiosity to commercial reality. Here's what happens when moss meets the brutal economics of bioprocessing.In Part 1, you've heard the science behind moss-based protein production. Now comes the real test: Can it survive the gauntlet of regulatory scrutiny, cost pressures, and manufacturing scale-up that crushes most biotech innovations?In Part 2 of this groundbreaking conversation, David Brühlmann and Andreas Schaaf, Managing Director and CSO of Eleva, dive into the nuts and bolts of what it actually takes to commercialize a revolutionary production platform. Andreas doesn't just theorize—he's lived through 15+ years of transforming Eleva from startup concept to clinical-stage reality, navigating every regulatory hurdle and economic challenge along the way.Three game-changing advantages that caught our attention:Process Robustness That Actually Works: While CHO cells throw tantrums over minor parameter shifts, moss maintains consistent product quality even when your bioprocess isn't behaving perfectly; a lifeline for manufacturing teams dealing with real-world variability.Economics That Make CFOs Smile: Forget expensive viral filtration steps and costly human pathogen testing. Moss's plant heritage eliminates these animal-system burdens, directly impacting your bottom line in ways that matter.Operational Simplicity: Variability in process ingredients and streamlined cell banking contribute to long-term cost and operational efficiencies that compound over time.Andreas shares hard-won insights about what it really takes to challenge entrenched bioprocessing orthodoxy, including the regulatory conversations, the economic realities, and his advice for scientists brave enough to pursue game-changing innovations.Ready to understand how disruptive biotechnology actually makes it from bench to bedside?Connect with Andreas Schaaf:LinkedIn: www.linkedin.com/in/andreas-schaaf-b3797716Website: www.elevabiologics.comNext 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/🧬 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

What if the future of "impossible" protein therapeutics is hiding in your backyard?For decades, CHO cells have ruled the biotech kingdom as the undisputed champions of complex protein production. But here's the uncomfortable truth: countless breakthrough therapies are gathering dust on laboratory shelves—not because the science failed, but because traditional hosts can’t produce them.Enter moss. Yes, moss. That humble green organism clinging to rocks and trees might just be the biotech industry's best-kept secret.In this eye-opening episode, David Brühlmann sits down with Andreas Schaaf, Managing Director and CSO of Eleva, who's spent over 20 years turning the "impossible" into reality. Andreas didn't just stumble upon moss; he co-developed Eleva's revolutionary moss-based platform from wild concept to commercial-scale game-changer, propelling the company into clinical trials.Here are three reasons why this episode is worth listening to:Moss as a Game Changer: More than a plant, moss is a higher eukaryote with mammalian-like protein production, including post-translational modifications and human-compatible glycosylation.Overcoming Bioprocessing Barriers: CHO cells are the industry gold standard, especially for monoclonal antibodies. But what about the therapeutic proteins that CHO can’t handle? Many promising candidates end up shelved—not because the science isn't sound, but because existing production platforms hit their limits.Bioprocessing, Simplified: Moss grows in standard bioreactors using familiar workflows—just with a whole organism instead of suspended cells.Curious about how plant-based systems could solve your protein production challenges? Dive into this episode to discover how moss could revolutionize your approach to challenging proteins; and let us know about your own production hurdles.Connect with Andreas Schaaf:LinkedIn: www.linkedin.com/in/andreas-schaaf-b3797716Website: www.elevabiologics.comNext 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/🧬 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

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: jeffrey.allen@eviabio.comNext 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

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: jeffrey.allen@eviabio.comNext 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/🧬 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

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: thomas.valentin@csem.chNext 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/🧬 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

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: thomas.valentin@csem.chNext 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 Ca🧬 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

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: anika.hoffmann@hevs.chNext 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