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

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

By: David Brühlmann - CMC Development Leader Biotech C-level Advisor Business Strategist
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About this listen

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

© 2026 Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
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Episodes
  • 226: Mastering Radiopharmaceutical Development: Preclinical Model Selection for Clinical Success with Bryan Miller - Part 2
    Feb 5 2026

    Hard-to-treat cancers like pancreatic ductal adenocarcinoma (PDAC) have long defied conventional therapies. Radiopharmaceuticals, combining targeted therapy with diagnostic power, are creating new opportunities in precision oncology.

    Host David Brühlmann speaks with Bryan Miller of Crown Bioscience, who explains how Crown's strategic partnerships, rigorous quality standards, and adaptive study design are shaping radiopharmaceutical development—delivering speed, safety, and real clinical impact.

    In this episode, you'll learn:

    • The promise and practical implications of theranostics—agents used for both diagnosis and treatment (02:44)
    • Definitions and distinctions between CDX (cell line-derived xenograft) and PDX (patient-derived xenograft) models, and why PDX models better recapitulate tumor heterogeneity (05:11)
    • Strategies for building more predictive, clinically relevant research models (06:09)
    • Balancing rapid innovation with rigorous quality standards—why robust QC systems enable speed without compromising safety (08:01)
    • Key advice for scientists entering radiopharmaceutical development, including how to choose the right research partners (09:53)
    • Why effective collaboration between biotech companies and CROs is akin to a well-chosen partnership (10:50)
    • The future outlook for radiopharmaceuticals and their impact on hard-to-treat cancers (12:21)

    Strategic insight:

    Focusing on theranostic radiopharmaceuticals—agents that combine diagnostics and therapy—offers a high-impact strategy for hard-to-treat cancers like PDAC. By enabling simultaneous patient stratification and targeted treatment, theranostics can accelerate development, improve clinical outcomes, and create a competitive advantage in areas where traditional therapies are limited.

    Where do you see radiopharmaceuticals and advanced preclinical models making the biggest impact in oncology or beyond?

    Explore the full conversation to learn how Bryan Miller and Crown Bioscience are scaling innovation for the next generation of cancer therapies.

    Connect with Bryan Miller:

    LinkedIn: www.linkedin.com/in/bryan-miller-148344aa

    Crown Bioscience: www.crownbio.com

    Next step:

    Need fast CMC guidance? → Get rapid CMC decision support here

    Support the show

    Show More Show Less
    16 mins
  • 225: Mastering Radiopharmaceutical Development: Preclinical Model Selection for Clinical Success with Bryan Miller - Part 1
    Feb 3 2026

    Imagine treating cancer with the precision of a guided missile—delivering radioactive payloads directly to tumor cells. Radiopharmaceuticals are reshaping cancer diagnostics and therapy by pairing tumor-targeting molecules with radioisotopes for diagnosis or therapy. But what does it really take to develop these therapies, and why is interest from scientists, biotech companies, and pharma accelerating?

    In this episode, we're joined by Bryan Miller, Director of Scientific and Technical Operations at Crown Bioscience UK. From a PhD in cardiac disease to leading preclinical oncology and radiopharmaceutical programs, Bryan brings hands-on insight into building advanced cancer models and translating innovative therapies from bench to clinic.

    Topics discussed include:

    • Bryan Miller's path from cardiac disease research to leading preclinical cancer model development (03:03)
    • Crown Bioscience's comprehensive cancer model platforms, from organoids to PDX and humanized in vivo models (04:05)
    • How radiopharmaceuticals differ from traditional chemotherapies in terms of safety and speed, including the concept of theranostics (07:32)
    • The reasons behind the surge of interest in radiopharmaceuticals within science and industry (09:04)
    • The importance of selecting the right preclinical model for success—and how AI and data-driven approaches will shape future workflows (10:11)
    • Critical pitfalls and unique technical challenges in radiopharmaceutical drug development (12:46)
    • Crown Bioscience's collaborative approach with Medicines Discovery Catapult to navigate the complexities of radiopharmaceutical research (13:35)
    • The diverse client needs, from small startups to global pharma companies, and how mature their development programs can be (14:20)
    • Strategies for scaling preclinical and translational capabilities to meet growing demand in radiopharmaceutical studies (16:04)

    Strategic insight:

    Radiopharmaceutical success requires integrated design from the start—combining precise model selection, targeting strategy, isotope choice, linker chemistry, and rigorous QC. Programs that establish this comprehensive foundation early move faster and with higher translational confidence than those addressing these elements sequentially or treating any aspect as a downstream refinement.

    If you're curious about the real challenges of drug development, the rise of theranostics, and how data-driven approaches (including AI) are shaping preclinical workflows, this episode delivers actionable strategies and insider perspectives for scientists and biotech innovators alike.

    Connect with Bryan Miller:

    LinkedIn: www.linkedin.com/in/bryan-miller-148344aa

    Crown Bioscience: www.crownbio.com

    Next step:

    Need fast CMC guidance? → Get rapid CMC decision support here

    Support the show

    Show More Show Less
    18 mins
  • 224: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang - Part 2
    Jan 29 2026

    The cultivated meat industry has captured headlines and struggled with economics. Meanwhile, plant cell biomanufacturing is quietly solving the cost equation and approaching commercial launch. The question isn't whether cellular agriculture can work at scale. It's which applications will get there first, and what bioprocessing innovations will make it possible.

    In Part 2, we dive into the commercialization challenges that separate laboratory curiosity from market-ready products. Steven Lang tackles the hard questions: How do you replicate chocolate's complex flavor profile without traditional fermentation? What analytical infrastructure ensures product consistency and safety? And how do you build the right team and data foundation to navigate the journey from premium launch to commodity-scale production?

    Steven's background spanning Johnson & Johnson, Genentech, and Upside Foods gives him a unique perspective on what works and what doesn't when translating biopharma rigor to food applications. At California Cultured, he's applying those lessons to launch high-flavanol cocoa powder in 2026, with a clear roadmap to commodity cocoa and coffee thereafter.

    In this episode:

    • The challenge of replicating chocolate’s taste and fermentation in the lab (02:39)
    • How plant cell culture differs from conventional farming and its advantages for safety and scalability (03:03)
    • Analytical methods and equipment needed for consistent, safe, and high-quality cultured cocoa products (05:05)
    • The potential for cell-based food to minimize heavy metals and other contaminants in chocolate (06:09)
    • Environmental implications: tackling climate change, deforestation, and the realistic timeline for widespread adoption of lab-grown foods (06:50)
    • Emerging opportunities beyond cocoa and coffee—saffron, ginseng, echinacea, and even lab-grown wood (08:40)
    • Key advice for scientists and entrepreneurs interested in entering the cellular agriculture field (10:12)
    • Building successful teams and robust data foundations in biotech startups (11:43)

    Key takeaway:

    Cellular agriculture's future isn't a single technology replacing conventional food production. It's multiple parallel approaches creating resilience in global food systems. The opportunity is clear: the technical principles you've mastered in biopharma translate directly to food applications, but the faster commercialization timelines and novel business models require rethinking what "stage-appropriate development" means.

    The question for bioprocess leaders is whether you'll help build the solutions to bridge the food production gap, or watch from the sidelines as food security becomes the defining challenge of our generation.

    Here is the previous conversation with Steven Lang:

    • Episodes 55-56: Cultivated Meat: A Promising Future or an Inevitable Bubble? with Steven Lang

    Connect with Steven Lang:

    LinkedIn: www.linkedin.com/in/steven-lang-b003406

    California Cultured Inc.: www.cacultured.com

    Next step:

    Need fast CMC guidance? → Get rapid CMC decision support here

    Support the show

    Show More Show Less
    17 mins
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