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

• 210: From Batch to Continuous: Building Innovation Culture in Conservative Biotech Environments with Irina Ramos - Part 2

  From pandemic-speed vaccine deployment to AI-powered process control, what separates hype from real manufacturing transformation?The biotech industry faces a fundamental challenge: how do you maintain rigorous quality standards while accelerating development timelines, personalizing therapies, and adopting transformative technologies? The answer isn't found in chasing every innovation trend, it's in understanding which changes create genuine value and when to implement them across the product lifecycle.Irina Ramos brings a perspective earned through high-stakes execution. After leading the global technology transfer of AstraZeneca's COVID-19 vaccine, a project that compressed typical timelines while maintaining uncompromising quality standards, she's applying those lessons to the industry's next wave of challenges: phase-appropriate CMC strategy, the practical realities of AI integration, and building teams that bridge generational experience gaps in an era of rapid technological change.This conversation cuts through the noise. Irina discusses when continuous processing actually makes strategic sense (hint: it's not always the right answer), why AI in bioprocessing requires more human expertise rather than less, and the collaborative frameworks that enabled one of the fastest vaccine rollouts in history—lessons directly applicable to your current CMC challenges.Episode highlights:How the biotech community is constantly changing, and the importance of adaptability for future scientists (00:00)Navigating phase-appropriate CMC strategy: What to focus on in early clinical phases and which decisions set the foundation for compliance (02:36)Scenarios for switching from batch to continuous processing, including barriers and benefits for early-stage vs. established products (02:58)Lessons from leading AstraZeneca's COVID-19 vaccine technology transfer: Collaboration, rapid regulatory communication, and mission-driven teams (05:20)Adapting lessons from the pandemic for ongoing drug development—balancing speed and risk while maintaining quality (08:24)Realistic perspectives on integrating AI in bioprocessing: demystifying its applications, emphasizing human-critical oversight, and practical use cases in manufacturing (10:40)Key skills for scientists in a biotech world shaped by AI—why foundational understanding and strong mentorship matter (13:51)Bridging experience gaps: How to foster collaboration and creativity between new and established professionals in regulated environments (15:45)Final takeaway: Start small, remain mission-driven, and remember that one size does not fit all in continuous manufacturing (17:15)Whether you're evaluating process platform decisions for Phase I programs, building cross-functional teams for tech transfer, or determining which digital tools deserve investment beyond the buzzword, this episode provides decision frameworks grounded in real-world execution at global scale.Connect with Irina Ramos:LinkedIn: www.linkedin.com/in/irinaramosNext step:Need fast CMC guidance? New on-demand CMC advisory: Get 20 expert answers/month in 1 day + monthly strategy call. → Learn more: https://stan.store/SmartBiotech/p/ondemand-cmc-expertise-for-biotech-foundersBook a 20-minute call to help you get s🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

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• 209: From Batch to Continuous: Building Innovation Culture in Conservative Biotech Environments with Irina Ramos - Part 1

  The biotech industry operates under constant tension: we work with products that directly impact human lives, demanding rigorous controls and validation at every step. Yet standing still means falling behind. The question isn't whether to innovate, it's how to do it without compromising the quality and safety standards that define our industry.Irina Ramos has lived this paradox throughout her career. As a downstream processing leader who's guided CMC programs from early development through global regulatory filings, she helped orchestrate the worldwide transfer of AstraZeneca's COVID-19 vaccine—a masterclass in balancing speed, scale, and uncompromising quality standards. Now, she's championing a vision that sounds almost radical: lights-out biomanufacturing facilities where continuous processes run at steady state with minimal human intervention.In this conversation, Irina shares the unfiltered reality of building innovation cultures in conservative environments, the surprising drivers behind continuous processing adoption, and why the industry's careful nature isn't a barrier to transformation. It's the foundation for sustainable innovation.Discussion highlights:Why conservatism is vital in biotech—and how to balance it with innovation (00:00)The vision for "lights-out" manufacturing and if bioprocess facilities could run with minimal human intervention (02:50)Irina Ramos's career story and the lessons her "happy accidents" teach junior scientists (03:53)Mindset shifts: Transitioning from scientist to innovation leader in CMC development (06:29)Building an innovation culture in a conservative, highly regulated industry (08:07)Essential mindsets for scientists to thrive and innovate in biotech environments (11:22)Coordination strategies for effective communication across stakeholders, departments, and geographies (13:52)The misconceptions of continuous manufacturing and what actually drives its adoption (17:09)What's hot in continuous biomanufacturing: trends, global perspectives, and how real-time analytics can change process control (21:12)Guiding principles for choosing between hybrid or end-to-end continuous processes (23:46)Practical tips on implementing control strategies and real-time monitoring in manufacturing (25:01)If you're navigating the shift from batch to continuous processing, leading cross-functional innovation initiatives, or wondering how to advocate for new technologies without disrupting validated processes, this episode offers practical frameworks you can apply immediately.Connect with Irina Ramos:LinkedIn: www.linkedin.com/in/irinaramosNext step:Need fast CMC guidance? New on-demand CMC advisory: Get 20 expert answers/month in 1 day + monthly strategy call. → Learn more: https://stan.store/SmartBiotech/p/ondemand-cmc-expertise-for-biotech-foundersBook a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://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

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• 208: Cryogenic Infrared Ion Spectroscopy: From Mass Spec Limitations to Molecular Precision with Tom Rizzo - Part 2

  What if you could analyze every metabolite, glycan variant, and unknown impurity in your bioprocess sample—not just the targets you're looking for, but everything that's actually there? Cryogenic infrared ion spectroscopy combined (CIRIS) with AI-powered analysis transforms untargeted screening from aspiration to reality.This episode moves from fundamental principles to practical applications. While Part 1 established how CIRIS overcomes mass spectrometry's structural limitations, Part 2 reveals what becomes possible when you can definitively identify complex mixtures: better mAb characterization, earlier disease detection, and process decisions based on complete data rather than educated guesses.Professor Tom Rizzo returns to discuss Isospec Analytics' path from laboratory innovation to commercial service platform. His transition from academic leadership at EPFL to biotech entrepreneurship offers insights for any scientist considering whether breakthrough research deserves a startup—and what that journey actually requires.For bioprocess scientists drowning in unidentified peaks, struggling with glycan heterogeneity, or making critical manufacturing decisions with incomplete analytical data, this conversation demonstrates how next-generation analytics powered by quantum chemistry and machine learning can illuminate what's been hidden in your samples all along.Episode Highlights:Why targeted metabolomics creates a "streetlight effect"—and how untargeted CIRIS analysis reveals the complete molecular landscape (00:00)Isomer-specific glycan characterization for mAbs: distinguishing structural variants that impact efficacy and immunogenicity (03:17)Advanced disease detection and biomarker discovery: identifying diagnostic signatures in complex biological matrices (05:21)AI meets quantum chemistry: automated spectral library building and machine learning algorithms that accelerate molecule identification from hours to seconds (06:05)From data generation to decision-making: how comprehensive analytics and AI transform bioprocess development workflows (09:23)Isospec's commercial roadmap: service platform for comprehensive sample analysis and projected timeline for benchtop instrumentation (10:09)Academic to entrepreneur: Tom Rizzo's perspective on leaving tenure for a startup, with practical advice for scientists evaluating the leap (12:05)Personal motivation behind early diagnostics: cancer and leukemia experiences that drive Isospec's clinical applications (14:11)Technical deep dive: messenger tagging methodology and achieving single-ion infrared detection sensitivity (15:41)The transformative capability: adding a structural dimension to mass spec data that eliminates ambiguity in complex mixture analysis (17:55)Mass spectrometry tells you what masses are present. Cryogenic infrared ion spectroscopy tells you what molecules they actually are. When coupled with AI-powered analysis, this combination enables truly comprehensive characterization—from process impurity identification to critical quality attribute assessment to early disease biomarker discovery.If you're making bioprocess decisions with incomplete analytical information, managing glycan complexity in biologics development, or exploring how emerging analytical technologies could solve your toughest characterization challenges, this episode provides both the technical foundation and the commercial pathway forward.🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

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• 207: Cryogenic Infrared Ion Spectroscopy: From Mass Spec Limitations to Molecular Precision with Tom Rizzo - Part 1

  What if you could identify every structural variant in your biologics—without ambiguity, without massive sample requirements, and without the guesswork that plagues traditional mass spectrometry? Cryogenic infrared ion spectroscopy (CIRIS) makes it possible, transforming molecular characterization from frustrating puzzle to precise science.Today's guest, Professor Tom Rizzo, bridges the gap between academic innovation and industrial application. As former Dean of the School of Basic Sciences at EPFL in Lausanne and now Chief Scientific Officer at Isospec Analytics, Tom has spent over two decades developing analytical techniques that solve problems conventional methods can't touch.His journey from a childhood fascination sparked by chemistry demonstrations at the 1964 New York World's Fair to pioneering a breakthrough technology reveals both the persistence required for true innovation and the pathway from laboratory curiosity to commercial reality. For bioprocess scientists struggling with glycan characterization, isomer identification, or any structural puzzle where mass spec alone falls short, this conversation offers both validation and solutions.Episode Highlights:The fundamental limitations of current biomolecular analysis methods and why innovation is critical (02:51)From World's Fair chemistry demos to laser spectroscopy: Tom Rizzo's path to analytical innovation (03:31)The two-decade quest to combine mass spectrometry sensitivity with laser spectroscopy precision—and the machine that finally made it work (04:26)Why Tom transitioned from academic leadership to Isospec Analytics: bringing lab techniques to production environments (09:17)CIRIS fundamentals: how cooling ions to 10 Kelvin unlocks molecular fingerprints that room-temperature methods miss (11:14)CIRIS advantages for biologics: single-ion sensitivity, isomer discrimination, and unique molecular "fingerprints" for definitive identification (14:25)Integrating CIRIS into existing bioprocess workflows: LC-MS compatibility and the path to commercial instrumentation (17:29)Hard-won lessons from translating academic breakthroughs into industrial tools (17:43)When mass spectrometry hits its limits—distinguishing isomers, characterizing glycans, identifying unknowns in complex mixtures—cryogenic infrared ion spectroscopy provides the structural resolution you need. This isn't incremental improvement; it's a fundamental expansion of what's analytically possible.If you're facing molecular identification challenges that conventional methods can't solve, or if you're curious how next-generation analytical techniques will transform bioprocess development, this episode delivers actionable insights from a scientist who's lived both the innovation and implementation journey.Connect with Tom Rizzo:LinkedIn: www.linkedin.com/in/thomas-rizzo-4a0a6314/Contact email: [email protected] Analytics website: www.isospecanalytics.comNext step:Need fast CMC guidance? New on-demand CMC advisory: Get 20 expert answers/month in 1 day + monthly strategy call. → Learn more: https://stan.store/SmartBiotech/p/ondemand-cmc-expertise-for-biotech-founders🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

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• 206: Process Economics Decoded: How to Model Biomanufacturing Costs From Clinical to Commercial Scale with Niklas Jungnelius - Part 2

  Carbon neutrality goals are everywhere in biopharma. But how do you actually measure and reduce your true environmental impact when data gaps and baseline differences make comparisons so tough?In this episode, David Brühlmann talks with Niklas Jungnelius, Cytiva’s expert in process modeling and sustainability, who’s spent years uncovering what really drives emissions and how small process tweaks can deliver big results.Niklas goes beyond the numbers, challenging assumptions and showing how sustainability becomes a strategic, data-driven advantage. From real-world cases at Cytiva, he explains why recycling plastics may not move the needle and why the real gains often lie in hotspots like cleanroom energy use and raw material choices.Here’s why this episode will make you rethink your next facility upgrade:Understanding life cycle assessment and the key damage categories in environmental sustainability, including carbon emissions, water usage, and resource depletion. (00:00)The challenge of defining carbon emissions baselines and why it’s harder, and often more expensive, to achieve deep reductions if your operations already use clean energy sources. (03:06)Why the focus on recycling single-use plastics may not be the most effective route for lowering emissions, and what truly drives carbon footprint in bioprocessing. (05:54)The impact of production scale, consumables, and obscure chemicals on the overall environmental impact and how these surprises can shift sustainability strategies. (06:20)Practical advice for scientists and engineers: How to start monitoring and modeling environmental impact in process development and manufacturing. (08:00)The importance of involving manufacturing perspectives early in process development, and choosing the right level of detail and ambition for process modeling. (08:18)There’s no one-size-fits-all in manufacturing technology—whether fed-batch, continuous, or hybrid and decisions must fit each organization’s needs, resources, and ambitions. (10:13)Industry trends that could transform the field, from intensified fed-batch production to future technologies like cell-free expression systems. (11:22)Where to connect with Niklas for further questions or collaboration. (14:03]Whether you’re an early-stage startup, a strategic advisor, or on the front lines of bioprocess development, this episode invites you to rethink your sustainability strategy and modeling approach. Check out the below links to connect with Niklas Jungnelius and additional resources.Connect with Niklas Jungnelius:LinkedIn: www.linkedin.com/in/niklas-jungneliusCytiva website: www.cytivalifesciences.com/en/usNext step:Need fast CMC guidance? New on-demand CMC advisory: Get 20 expert answers/month in 1 day + monthly strategy call. → Learn more: https://stan.store/SmartBiotech/p/ondemand-cmc-expertise-for-biotech-foundersBook a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://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

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