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

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

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

Auteur(s): David Brühlmann - CMC Development Leader Biotech C-level Advisor Business Strategist
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À propos de cet audio

The Go-to Podcast for Biotech Scientists Who Want to Master Biopharma CMC Development and Biomanufacturing.

**TOP 10 LIFE SCIENCES PODCAST**

Are you ready to simplify bioprocess development and scale with confidence to reduce time to market?

Are you feeling overwhelmed by the complexity and guesswork of biologics development and biomanufacturing?

Do you wish you had more time to enjoy the beauty of science, without worrying about failing your cell culture process development and commercialization?

There's a way to simplify and streamline so you can remove complexity, skip trials and errors, deliver your groundbreaking therapy to clinics and market without delay, and still enjoy every single step.

I'm David Brühlmann, a biotech entrepreneur and strategic advisor who partners with C-level biopharma leaders to tackle one of our industry's biggest challenges: reducing manufacturing costs to make lifesaving therapies accessible to more patients worldwide.

Through engaging conversations with industry pioneers and practical insights from the trenches, this podcast tackles the critical challenges in bioprocess CMC development and manufacturing of recombinant proteins and cell and gene therapy products. We cut through the complexity so you can:

  • Master bioprocess development with confidence and clarity


  • Excel at scale-up and manufacturing of biologics


  • Transform your innovative therapy and manufacturing technology into market-ready solutions faster


  • Optimize manufacturing costs without compromising quality


  • Make data-driven decisions that reduce the risk of failure


I can’t wait to help you do biotech the smart way.

Grab a cup of coffee and your favorite notebook and pen. Now is the time to take your bioprocessing game to the next level.

Ready to transform your biomanufacturing journey? Let's dive in!

Next Steps:

Book a free call to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/call


🧬 Ready to accelerate your IND timeline? Get the proven CMC Dashboard that's guided successful mAb programs from chaos to submission: https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders

Accelerate biologics development with expert guidance: https://bruehlmann-consulting.com


For sponsorship opportunities, contact us at hello@bruehlmann-consulting.com

Visit the Website: https://smartbiotechscientist.com

Email us: hello@bruehlmann-consulting.com

© 2025 Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
Science Sciences biologiques
Épisodes
  • 208: Cryogenic Infrared Ion Spectroscopy: From Mass Spec Limitations to Molecular Precision with Tom Rizzo - Part 2
    Nov 20 2025

    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-round

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    23 min
  • 207: Cryogenic Infrared Ion Spectroscopy: From Mass Spec Limitations to Molecular Precision with Tom Rizzo - Part 1
    Nov 18 2025

    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: tom@isospec.ch

    Isospec Analytics website: www.isospecanalytics.com

    Next step:

    Book 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-round

    Support the show

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    23 min
  • 206: Process Economics Decoded: How to Model Biomanufacturing Costs From Clinical to Commercial Scale with Niklas Jungnelius - Part 2
    Nov 13 2025

    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-jungnelius

    Cytiva website: www.cytivalifesciences.com/en/us

    Next step:

    Book 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-round

    Support the show

    Voir plus Voir moins
    18 min
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