Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

Shear sensitivity is the silent challenge behind many advanced biomanufacturing modalities. Orbital-shaken bioreactors—often underestimated—may be a key enabler your CMC development is missing. Tibor Anderlei, CSO at Kühner Shaker, joined David Brühlmann on the Smart Biotech Scientist Podcast to unpack the hidden physics behind bioprocess reproducibility and next-generation shaking technology. He has seen firsthand how overlooking fundamental parameters can derail scale-up and delay development timelines. In his role, Tibor is responsible for the customer interface—spanning sales, service, support, GMP topics, troubleshooting, marketing, and applied technology—with a focus on orbital shaking technology and small-scale cultivation support. Topics discussed: Smart insight: Treat small-scale shaken systems as real bioreactors and define screening conditions carefully from the start. Using online measurement tools even at early stages provides critical visibility and helps ensure that results are reproducible and scalable. Building a robust scale-up strategy requires looking at the process from multiple angles—regulatory, digital, and operational. Listen to those previous episodes: Connect with Tibor Anderlei: LinkedIn: www.linkedin.com/in/tibor-anderlei-66342411/ Kühner Shaker website: www.kuhner.com Shaking Technology Forum: www.shakingtechnology.com Support the show

Why do small-scale bioprocess experiments often fail to translate in scale-up despite “perfect” results on paper? Tibor Anderlei, Chief Scientific Officer and leader of customer support at Kühner Shaker, has spent three decades solving an issue that frustrates CMC leaders and biomanufacturing teams worldwide. He pioneered online monitoring in shake flasks, co-founded AC Biotec, and now helps organizations avoid costly trial-and-error with high-throughput screening and orbital shaken bioreactors. Topics discussed: Smart insight: If scientists want scalable, reproducible success, the path starts with getting the details right—and keeping a sharp eye on both automation trends and the fundamentals of shaken cultures. Listen to the full episode with Tibor Anderlei to unpack the real “missing links” in bioprocess reproducibility and how to bridge small-scale insight to CMC scale-up. Building a robust scale-up strategy requires looking at the process from multiple angles—regulatory, digital, and operational. Listen to those previous episodes: Connect with Tibor Anderlei: LinkedIn: www.linkedin.com/in/tibor-anderlei-66342411/ Kühner Shaker website: www.kuhner.com Shaking Technology Forum: www.shakingtechnology.com One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month. Support the show

When a single mismanaged tech transfer threatens an entire development program, pressure on CMC leaders and bioprocess teams is intense. The truth? Tech transfers aren’t a black box. They’re complex, but solvable with the right mindset and playbook. In this episode, David Brühlmann explores the practical side of tech transfer and scale-up within the biotech industry. With more than 15 years of experience, he shares personal stories and industry-tested frameworks that help demystify the complexities of transferring technologies between sites or organizations. Instead of focusing solely on technical details, he emphasizes the crucial human and organizational factors that often decide project success or failure. Key topics discussed: Whether you're overseeing a complex CMC program, navigating CDMO relationships, or planning your next scale-up, this episode offers concrete steps to cut through confusion and deliver results. If you’re interested in the ideas discussed, here are some of the guests David referenced in this episode. Support the show

What if the hidden cost of your bioprocess lies not in the technology, but in what you don’t document? Too often, biotech teams discover too late that their “proven” process is just an illusion, propped up by undocumented tricks and missing critical parameters. In this episode, David Brühlmann strips down the assumptions behind scale-up and tech transfer, exposing the silent risks that threaten CMC milestones and market launches alike. After 15 years guiding biotech projects from bench to clinic, he’s felt the pain of process gaps, regulatory curveballs, and million-dollar mistakes. Here, he turns that experience into a tactical guide designed to save you from the same pitfalls. In this episode, you’ll learn about: This episode sets the stage for Part 2, where David Brühlmann will share practical stories and detailed frameworks for real-world implementation. If you manage bioprocess scale-up, tech transfer, or CMC development, you’ll find plenty of actionable insights to apply in your own work. If you’re interested in the ideas discussed, here are some of the guests David referenced in this episode. Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

What if the solution to cell therapy’s biggest cold-chain challenge comes from the biology of Arctic fish? This conversation features Steve Oh, a leader in advanced bioprocessing, whose career has placed him at the intersection of stem cell biology, process engineering, and clinical translation. Steve Oh joins David Brühlmann to share how XT Thrive®—a next-generation cryopreservation solution drawing from nature’s antifreeze proteins—lets cells survive, thrive, and simplify manufacturing from the bench to the clinic. Episode highlights: Smart insight: Next-generation cryopreservation solutions address more than just viability—they simplify transport, reduce costs, lower hands-on time, and help ensure therapy reaches patients in remote locations in optimal condition. As Steve Oh observes, these advances are critical for reducing the cost of goods, improving consistency, and enabling truly scalable cell therapy manufacturing. If you’re interested in this topic, check out these episodes, where we explore how Minnesota’s frozen forests inspired a new wave of biotech innovation—transforming how life-saving cells are frozen, stored, and shipped. This is Steve’s second appearance on the podcast. You can also catch his earlier conversation with David, where they explored the challenges and opportunities of cell and gene therapy. Connect with Steve Oh: Email: skwohso@gmail.com LinkedIn: www.linkedin.com/in/steve-oh-4946261/ Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

Arctic fish survive in waters that would freeze most life solid. Not because they tolerate ice, but because their biology prevents crystals from forming in the first place. That same principle, translated into synthetic peptide chemistry, is now showing performance data that DMSO cannot match. Part 2 is where the science becomes practical. Steve Oh spent 22 years at Singapore's A*STAR accumulating 43 patents across stem cell bioprocessing, microcarrier technologies, and serum-free media. He now advises XTherma, where he has been stress-testing their DMSO-free cryopreservation solution across T cells, MSCs, organoids, and beyond. In Part 2, he brings the data. Key topics discussed: Smart insight: The transition away from DMSO is more accessible than most scientists assume. XT Thrive is GMP-grade, carries a Drug Master File, and is used at the same 5-10% concentration as DMSO, making it a plug-and-play substitution for most cell types. The manufacturing implications go further: no wash step, extended hold times, and storage stability across all standard temperature ranges simplify both production workflows and cold-chain logistics to remote treatment sites. If you’re interested in this topic, check out these episodes, where we explore how Minnesota’s frozen forests inspired a new wave of biotech innovation, transforming how life-saving cells are frozen, stored, and shipped. This is Steve’s second appearance on the podcast. You can also catch his earlier conversation with David, where they explored the challenges and opportunities of cell and gene therapy. Connect with Steve Oh: Email: skwohso@gmail.com LinkedIn: www.linkedin.com/in/steve-oh-4946261/ Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

Why do CDMOs keep building bigger stainless-steel facilities while their margins erode and Asian competitors undercut them on price? And what happens when big pharma decides to stop outsourcing altogether? The business model that sustained the industry for two decades is under pressure from every direction, and for many CDMOs, standing still is no longer a neutral position. In Part 2, Juergen Mairhofer, CEO of enGenes Biotech, shifts from the science to the stakes. Having spent over a decade building a company on licensing proprietary microbial technology rather than selling fermentation capacity, he brings a distinctive vantage point on where the CDMO industry is headed and what it will take to stay relevant. Here are some of the topics discussed: Smart insight: Technology excellence is necessary but not sufficient. Juergen's closing word was simply "don't be afraid" and it carried weight precisely because it was not a platitude. The companies that will matter in ten years are those that start the hard work of innovation now, before the window closes. If you’re interested in exploring more breakthroughs in continuous bioprocessing and the future of biotech manufacturing, check out these past episodes from the Smart Biotech Scientist Podcast: Connect with Juergen Mairhofer: LinkedIn: www.linkedin.com/in/juergen-mairhofer-ab27a5b enGenes Biotech GmbH website: www.engenes.cc Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

What if continuous microbial manufacturing wasn't a pipe dream, but a reality quietly reshaping the foundations of bioprocessing? Meet Juergen Mairhofer, CEO of enGenes Biotech GmbH and a scientist with a rare dual fluency in molecular biology and bioprocess engineering. He's not just optimizing at the margins. He's devised a proprietary E. coli platform that radically stabilizes genetic stability and splits cell growth from protein production. Instead of stretching out fermentation for a few more days, he's running continuous E. coli processes for up to 40 days; something most believed impossible. Here's why this conversation is worth your notebook and a second listen: Smart insight: Technology excellence is the entry ticket, but it won't sell itself. The companies that will lead the next decade of bioprocessing are those willing to align their business model with process innovation, not just capacity utilization. If you’re interested in exploring more breakthroughs in continuous bioprocessing and the future of biotech manufacturing, check out these past episodes from the Smart Biotech Scientist Podcast: Connect with Juergen Mairhofer: LinkedIn: www.linkedin.com/in/juergen-mairhofer-ab27a5b enGenes Biotech GmbH website: www.engenes.cc Next step: Need fast CMC guidance? → Get rapid CMC decision support here One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month. Support the show

For many biotech innovators, high-throughput screening platforms promise faster discoveries and streamlined workflows. Yet beneath the surface, the reality is more demanding, requiring hands-on expertise, careful assay design, and a sharp understanding of microbial physiology to avoid mistakes that become expensive to fix downstream. David Brühlmann continues his conversation with Sebastian Blum, Market Development Manager in Europe at Beckman Coulter Life Sciences, who brings a practical, unvarnished perspective to high-throughput screening. Drawing on conversations with startups, pharma, and CDMOs, Sebastian digs into what separates "push-button" automation myths from hard-won bioprocess mastery. From evaluating technical fit to troubleshooting real-world applications, he advocates for a nuanced approach, one focused on fit-for-purpose tools and critical thinking over technology hype. In this episode, we discuss: If you're making decisions about high-throughput screening platforms and want to avoid costly missteps before scale-up, this episode delivers the clarity you need. Connect with Sebastian Blum: LinkedIn: www.de.linkedin.com/in/sebastian-blum-76240b3b Beckman Coulter Life Sciences: www.beckman.com Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

Why do so many promising biotech ideas stall long before they reach the clinic or marketplace? For many, the answer lies hidden in the earliest phase of bioprocess development: upstream processing. It’s where strain selection, media optimization, and culture conditions set the stage for everything that follows. Yet, the smallest missteps here can snowball into expensive roadblocks downstream. This episode of Smart Biotech Scientist Podcast zeros in on why smart screening strategies and the right bioreactor choices early on are the difference between breakthrough and bottleneck. Joining host David Brühlmann is Sebastian Blum, a microbiologist with more than two decades in the life sciences. As Market Development Manager at Beckman Coulter Life Sciences, Sebastian Blum brings firsthand knowledge from collaborating with startups, pharma giants, and CDMOs, bridging theory with the practical realities of modern process development. From commercializing micro-fermentation systems to guiding clients through high-throughput data, his insights come not just from research but real-world applications. Key Topics & Insights: This episode offers grounded advice for scientists and founders navigating early-stage bioprocess development, plus a clear look at the technology landscape for microbial screening and optimization. Perfect for those looking to streamline process development and avoid common pitfalls. Connect with Sebastian Blum: LinkedIn: www.de.linkedin.com/in/sebastian-blum-76240b3b Beckman Coulter Life Sciences: www.beckman.com Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

For years, mammalian cells and microbial systems have dominated the biotech landscape, shaping the economics and access to life-saving biologics. Yet, in countries where capital and infrastructure are limited, those gold-standard systems bring hefty price tags and daunting complexity. The answer isn't bigger bioreactors; it's alternative biomanufacturing approaches, such as molecular farming. Imagine medicines grown like crops, ready for harvest in days, not months. Meet Waranyoo Phoolcharoen, Co-Founder and CTO of Baiya Phytopharm and Professor at Chulalongkorn University in Bangkok, a scientist who didn't settle for the status quo. As the driving force behind the company, she led the charge to cut through process bottlenecks: navigating regulatory hurdles, scaling plant-based vaccine manufacturing to 5 million doses per month, and reshaping the approach to antibody production for oncology and infectious diseases. Her work proved that plants aren't an alternative. They're a platform. Topics discussed include: Smart insight: Platform choice matters. If you're struggling with long development timelines or scale-up challenges, it may not always be the molecule. It may be the system you're using. Molecular farming offers a different set of trade-offs: faster development, flexible scaling, and a practical alternative worth considering before defaulting to a single platform. If you’re interested in other unconventional biological platforms reshaping biomanufacturing, don’t miss these episodes exploring emerging production technologies: Connect with Waranyoo Phoolcharoen: Email: Waranyoo.P@baiyaphytopharm.com Baiya Phytopharm website: www.baiyaphytopharm.com Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

Imagine producing life-saving antibodies or vaccines not in sprawling stainless steel facilities, but in sunlit greenhouses, inside living, breathing plants. Waranyoo Phoolcharoen, Co-Founder and CTO of Baiya Phytopharm and Professor at Chulalongkorn University in Bangkok, leads the charge in molecular farming in Thailand, pioneering a shift from traditional biomanufacturing toward using whole plants as responsive biofactories. With a unique background in both pharmaceutical sciences and plant biotechnology, she has taken her research out of the academic silo and into the world, founding a clinical-stage company determined to make vaccines and therapeutic proteins accessible where they're needed most. In this episode, we cover: Smart insight: The most important mindset shift from scientist to entrepreneur isn't technical; it's learning to ask different questions. Not "is this interesting?" but "who will pay for this, and does it make commercial sense?" As Waranyoo puts it, when you have the right question, it leads to the right answer. Stay tuned for Part 2, where we'll explore platform capabilities and Asia's first plant-derived COVID-19 vaccine to enter clinical trials. If you’re interested in other unconventional biological platforms reshaping biomanufacturing, don’t miss these episodes exploring emerging production technologies: Connect with Waranyoo Phoolcharoen: Email: Waranyoo.P@baiyaphytopharm.com Baiya Phytopharm website: www.baiyaphytopharm.com Next step: Need fast CMC guidance? → Get rapid CMC decision support here One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month. Support the show

Picture a new bioprocess automation project: ambitious, expensive, and packed with promise. But after months of development, your team discovers a flaw that could have been caught with a simple mockup and a few sticky notes on a whiteboard. This episode confronts the real cost of skipping discovery, premature automation, and the myth that faster engineering always means faster solutions. Anthony Catacchio, CEO of Product Insight, continues his conversation with David Brühlmann to untangle the realities of automation strategy in biotech. Drawing from years of building robotics for high-stakes labs, Anthony explores why "minimum testable product" consistently outperforms "minimum viable product" when budgets, timelines, and patient outcomes are on the line. Highlights from the episode: Smart insight: Automation is not a technology problem, it is a systems development and requirements development problem. The teams that deeply understand their process and environment before touching a line of code or a line of engineering will always outperform those that do not. As Anthony puts it: you need to look at the whole picture. Connect with Anthony Catacchio: LinkedIn: www.linkedin.com/in/anthony-catacchio-b881581b Product Insight website: www.productinsight.com Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

Many bioprocess automation projects fail, not because the technology is wrong, but because no one clearly defined the problem before buying the robot. In this episode, David Brühlmann sits down with Anthony Catacchio, CEO of Product Insight, to explore why rigorous system design and honest problem definition matter more than any individual technology, and how industrial robotics expertise translates directly into smarter lab automation. Highlights from the episode: Smart insight: The most expensive automation mistake happens at the whiteboard, not on the manufacturing floor. Define the problem with surgical precision before you ever evaluate a solution. In Part 2, the conversation continues with a deeper look at building automation systems that deliver practical solutions to bioprocessing challenges without overengineering. Tune in for practical strategies and honest reflections on automation, system design, and the importance of clear problem definition in biotech hardware development. Connect with Anthony Catacchio: LinkedIn: www.linkedin.com/in/anthony-catacchio-b881581b Product Insight website: www.productinsight.com Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

How solid is your CMC foundation—and what happens if it cracks under pressure? David Brühlmann welcomes Henri Kornmann, former Head of Biologics Innovation Centre at Ferring Pharmaceuticals. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has moved repeatedly between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs. His “house building” approach demystifies CMC’s complexity, showing why early diligence paired with regulatory fluency and scientific insight pays dividends for years. Tune in to hear Henri’s practical wisdom distilled through real-world analogies: Smart insight: Never underestimate CMC. If you do, you will pay for it later. If this topic resonates with you, here are a few related episodes where we dive deeper into building strong CMC foundations and avoiding costly development mistakes: Connect with Henri Kornmann: LinkedIn: www.linkedin.com/in/henri-kornmann-9b6869 Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

Seventy percent of FDA Complete Response Letters have a CMC root cause. Most of those failures trace back to decisions made years earlier. Decisions that felt minor at the time and proved impossible to fix later. Henri Kornmann has spent two decades making those decisions the right way. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has crossed between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs. His conclusion: a CMC program is like building a house. Get the foundation wrong and no amount of late-stage effort will save you. In Part 1, Henri reveals the decisions that cannot be undone and how to get them right from the start. What you will learn: Smart insight: The therapies that reach patients aren't built on heroic late-stage rescues. They're built on disciplined early decisions: the right cell bank, the right analytics, the right documentation. Henri's message is unambiguous: there are CMC mistakes you can fix later, and there are CMC mistakes you cannot. Knowing the difference is the foundation of every successful biologics program. In Part 2, Henri walks through scale-up to commercial manufacturing, process validation stages 1 through 3, post-approval control strategy, and the project management and regulatory fluency that separate successful CMC leaders from the rest. If this topic resonates with you, here are a few related episodes where we dive deeper into building strong CMC foundations and avoiding costly development mistakes: Connect with Henri Kornmann: LinkedIn: www.linkedin.com/in/henri-kornmann-9b6869 Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

What if the future of sustainable manufacturing required no sugar feedstocks, generated minimal waste, and operated carbon-neutral from day one? Ocean-derived cyanobacteria are making this possible—but the path from promising strain to profitable business is littered with synthetic biology casualties. This episode reveals the strategic decisions that separate winners from failures. In Part 2, Tim Corcoran, CEO and Co-Founder of Deep Blue Biotech, exposes the hard truths about commercializing photosynthetic manufacturing: why most synthetic biology companies died when capital dried up in 2023, which infrastructure gaps nearly derail cyanobacteria scale-up, and why building one facility beats building ten. With three decades navigating commercial biotech and operations, Tim shares the disciplined commercialization framework that transforms scientific breakthroughs into economically viable platforms. Topics covered: Strategic insight: Breakthrough science needs disciplined commercialization. Align what your technology naturally excels at with market needs, start where value is highest, and leverage partnerships to scale. As Deep Blue Biotech shows, this is how innovations move from the lab to making a real-world impact. Explore the full story and hear Tim’s advice for both founders and innovators. If you’re interested in other unconventional biological platforms reshaping biomanufacturing, don’t miss: Connect with Tim Corcoran: LinkedIn: www.linkedin.com/in/tim-corcoran-5b10121/ Deep Blue Biotech: www.deepbluebiotech.com Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

The chemicals industry remains locked into carbon-intensive, fossil-based manufacturing. Even engineered microbes like yeast or E. coli depend on expensive sugar feedstocks while generating significant waste. What if a photosynthetic organism could eliminate those constraints entirely—while commanding premium pricing as "ocean-derived"? On the Smart Biotech Scientist Podcast, Tim Corcoran, CEO and Co-Founder of Deep Blue Biotech, reveals how a recently discovered fast-growing marine cyanobacteria strain is unlocking carbon-neutral chemical production at costs below conventional fermentation. With his background spanning economics, operations, and innovation commercialization, Tim challenges conventional assumptions about synthetic biology scale-up, market entry strategy, and what actually separates successful biotechs from valley-of-death casualties. Key topics discussed: Strategic insight: Deep Blue Biotech's "premium-first commercialization" mirrors Tesla's playbook: start with high-margin applications ($2,000/kg hyaluronic acid for personal care) to generate immediate revenue and prove the platform. These early profits fund continuous strain engineering and process optimization, progressively driving down cost-of-goods while improving volumetric productivity. Only after establishing economic viability at premium pricing does the company target large-volume commodity markets—sustainable fuels, industrial chemicals—where success requires demonstration of competitive economics at industrial scale. Discover how this photosynthetic organisms could decarbonize entire chemical supply chains while improving manufacturing economics. Part 2 reveals the strategic decisions separating synthetic biology winners from failures, photobioreactor infrastructure challenges, and why licensing beats building multiple facilities. If you’re interested in other unconventional biological platforms reshaping biomanufacturing, don’t miss: Conn One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month. Support the show

How early in process development should you address glycosylation? This episode presents the case for co-optimizing glycan profiles with productivity from initial process characterization. Deferring glycosylation characterization until after titer targets are met introduces risk: quality attribute gaps discovered late in development force process re-optimization, extended timelines, and potential cell line reselection. Media supplementation enables earlier intervention—tuning glycan distribution as a process parameter from the beginning of cell line and media development rather than as a remediation strategy. David Brühlmann outlines the experimental protocol for validating raffinose supplementation, including decision criteria for proceeding or terminating at each development stage. The discussion addresses process design space requirements, analytical monitoring strategy, and the experimental variables that determine when media-based glycan tuning is appropriate versus when alternative approaches are needed. Highlights from the episode: Strategic insight: Sequential optimization of productivity followed by glycosylation introduces development risk: quality attribute deviations discovered after process lockdown require costly re-optimization cycles. Parallel development of titer and glycan specifications from initial cell line characterization reduces this risk by establishing feasible operating windows early in the development timeline. Are you planning your next recombinant protein scale-up? Hear how David’s rule-of-three protocol and battle-tested lessons can help you optimize faster and avoid painful late-stage surprises. Resources: Journal of Biotechnology, 2017, volume 252, pages 32 to 42 Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

When your biosimilar analytical data shows 1.4% high mannose against a 6% reference product specification, you face limited options: process temperature shifts that compromise titer, kifunensine supplementation that requires extensive regulatory justification, or 12-18 months to reclone and revalidate. Media supplementation offers an alternative pathway—tuning glycan profiles through formulation adjustments rather than cell line or process re-engineering. In this episode, David Brühlmann presents the experimental development of a media supplementation strategy that achieved 2.8-fold increases in high mannose glycans across multiple CHO cell lines. Drawing from research published in the Journal of Biotechnology (2017, 252:32-42), the discussion covers the mechanism of raffinose-mediated glycan processing arrest, the experimental variables that initially obscured the effect, and the process development considerations for implementing media-based glycan tuning. The episode examines N-glycan biosynthesis in CHO cells, regulatory comparability requirements for biosimilar glycosylation profiles, and the experimental framework for evaluating media supplementation as a glycan control strategy. Highlights from the episode: Strategic insight: Implementing raffinose as a media supplement is straightforward, regulatory-friendly, and cost-effective. It does not involve genetic engineering or enzyme inhibitors and is easily sourced as a GMP-grade material. For programs approaching submission with glycan comparability gaps, media-based tuning offers a process optimization pathway that maintains existing cell lines and manufacturing platforms while addressing critical quality attribute specifications. Listen to this episode of the Smart Biotech Scientist Podcast to learn David’s best strategies for rapid, regulatory-friendly glycosylation control. If you want to transform your glycoengineering workflow, keep an eye (and ear) out for the next episode of the Smart Biotech Scientist Podcast. Your path to regulatory success might be as simple as a pinch of raffinose. Resources: Journal of Biotechnology, 2017, volume 252, pages 32 to 42 Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show