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

science · EN-US · 297 episodes

Audience: 7

About this Podcast:

The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error. Practical, execution-focused, and strategic guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics for biologics, cell and gene therapies, cultivated meat, and biomaterials. Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies. This podcast is for you if: You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnership You are a

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Verified email

Booking probability

37%

Guest openness

Selective

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85/100
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Questions about Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

What is Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders about?

The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error. Practical, execution-focused, and strategic guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics for biologics, cell and gene therapies, cultivated meat, and biomaterials. Hosted by Dr.

What has Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders covered recently?

Recent episodes include "297: 10,000 Structures Are Not Enough: The Data Gap Limiting De Novo Antibody Design with David Younger - Part 1" (20 October 2026, 28 minutes), "296: Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge with Matthew O'Connor - Part 2" (15 October 2026, 21 minutes), and "295: Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge with Matthew O'Connor - Part 1" (13 October 2026, 25 minutes).

How often does Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders publish?

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders publishes roughly weekly, with episodes averaging 22 minutes across 297 episodes.

How hard is it to get booked on Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders?

Booking probability for Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders is 37%, and the host is rated Selective on guests. Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders requires a Pod Score of 85 or higher. Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders's contact route on record: verified email.

Who should pitch Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders?

The strongest fits for Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders are Pharmaceuticals and Scientific Research & Development. Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders has a science audience.

About the host

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders is a science show with 297 episodes published.

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Recent episodes

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  • Episode #297

    297: 10,000 Structures Are Not Enough: The Data Gap Limiting De Novo Antibody Design with David Younger - Part 1

    Oct 20, 202628 min

    The Protein Data Bank holds about 10,000 antibody-antigen structures and grows by roughly 1,000 a year. David Younger's scaling work suggests that generalizable de novo antibody design needs hundreds of thousands to...

  • Episode #296

    296: Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge with Matthew O'Connor - Part 2

    Oct 15, 202621 min

    Cardiovascular disease has long been managed by slowing its relentless progression. But Matthew O'Connor, CEO of Scientific Affairs at Cyclarity Therapeutics, is betting on an outright paradigm shift: treating...

  • Episode #295

    295: Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge with Matthew O'Connor - Part 1

    Oct 13, 202625 min

    Why does CMC development still expect every drug to be one molecule with one peak, when new therapeutics don't always fit neatly into existing regulatory or chemical categories? Matthew O'Connor, CEO of Scientific...

  • Episode #293

    293: Is CFD Overkill for Your Scale-Up? Why It Belongs in Every Biotech Scientist's Toolkit with Christian Witz - Part 1

    Oct 6, 202623 min

    You've perfected your process at the bench. Now comes the part that keeps CMC scientists up at night: will it still work at 2,000L? Right now, most teams find out the hard way, through failed runs, wasted batches, and...

  • Episode #291

    291: The Fool's Game That Became Standard Practice: Perfusion, the ATF, and What Changed with John Bonham-Carter - Part 1

    Sep 29, 202631 min

    Biotech loves talk of disruptive technology, but few have repeatedly shifted the industry's direction. This episode of the Smart Biotech Scientist Podcast focuses on an idea once dismissed as a fool's game: process...

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  • Episode #290

    290: Batch-to-Batch Variability Is a Design Failure, Not the Norm with Sandra Núñez - Part 2

    Sep 24, 202620 min

    What if building a world-class biotech company didn’t require owning a single piece of manufacturing equipment or even a lab of your own? Most startups obsess over bricks, mortar, and stainless steel. Not Sandra Núñez...

  • Episode #289

    289: Batch-to-Batch Variability Is a Design Failure, Not the Norm with Sandra Núñez - Part 1

    Sep 22, 202619 min

    Batch-to-batch variability isn’t just a minor annoyance in bioprocess development; it’s often a systemic design flaw hiding in plain sight. That’s the challenge Sandra Núñez, CEO of Amela Biosciences, set out to...

  • Episode #288

    288: Why the Cell Line Is the CMC Decision You Don't Get to Undo with Sigma Mostafa - Part 2

    Sep 17, 202622 min

    Manufacturability challenges in biotech are becoming more complex as therapies become more potent, formats diversify, and timelines compress across the industry. On this episode, David Brühlmann sits down with Sigma...

  • Episode #287

    287: Why the Cell Line Is the CMC Decision You Don't Get to Undo with Sigma Mostafa - Part 1

    Sep 15, 202618 min

    A breakthrough in drug discovery can be derailed in an instant if manufacturability is left as an afterthought. Too many biotech programs hit bottlenecks at scale-up because key decisions in cell line and process...

  • Episode #286

    286: Why Your Dormant Omics Data Is Worth More Than the Data You'll Generate Next with Nathan Lewis - Part 2

    Sep 10, 202618 min

    What does it take to crack the code of protein production and why do some proteins stubbornly refuse to cooperate, despite the best efforts of scientists and engineers? Biotech’s ambitions are often limited not by...

  • Episode #285

    285: Why Your Dormant Omics Data Is Worth More Than the Data You'll Generate Next with Nathan Lewis - Part 1

    Sep 8, 202630 min

    Dormant omics data are a goldmine for CMC innovation waiting to be unlocked. But legacy structures, poor annotation, and spreadsheet chaos hold most biotech teams back from the real breakthroughs. Nathan Lewis, GRA...

  • Episode #284

    284: Detecting 1 in 100,000 Cells: DNA Barcoding for Smarter Clone Selection with Kent Rapp - Part 2

    Sep 3, 202621 min

    “Does DNA barcoding actually work?” It's the first question Kent Rapp hears from prospective customers when he pitches Biolinco's DNA barcoding platform. By his own admission, the technology can sound too good to be...

  • Episode #283

    283: Detecting 1 in 100,000 Cells: DNA Barcoding for Smarter Clone Selection with Kent Rapp - Part 1

    Sep 1, 202622 min

    What if the bottleneck in cell line development isn’t how many clones you screen, but how you track them? Cloning workflows have long relied on brute force: screen more cells, automate harder, and hope that small-scale...

  • Episode #281

    282: When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent with Jitendra Kumar - Part 2

    Aug 27, 202619 min

    Your active ingredient is the nucleic acid. So why does a proteolipid vehicle filing include viral clearance studies, stability data and full characterisation of a membrane protein that is not the drug? Because that...

  • Episode #280

    281: When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent with Jitendra Kumar - Part 1

    Aug 25, 202619 min

    Gene therapy only works if the cargo reaches the right cells intact. Adeno-associated viruses (AAV) and lipid nanoparticles have carried the field this far, but both share a constraint: the particle is taken up into an...

  • Episode #280

    280: Why Nanovesicles Outperform Exosomes: Scalable Drug Delivery Beyond Injectable Vaccines with Christopher Locher - Part 2

    Aug 20, 202616 min

    For decades, drug development has been saddled with costly manufacturing, stringent biosafety requirements, and the limits of conventional carriers. But a new approach—born from cell-derived nanovesicles—could...

  • Episode #279

    279: Why Nanovesicles Outperform Exosomes: Scalable Drug Delivery Beyond Injectable Vaccines with Christopher Locher - Part 1

    Aug 18, 202622 min

    What if the best way to unlock durable, broad-spectrum immunity is to rethink the very vessels delivering our vaccines? While much of the industry focuses on refining existing delivery systems, Christopher Locher is...

  • Episode #278

    278: Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins with Ignasi Bofarull-Manzano - Part 2

    Aug 13, 202619 min

    How do you take a model that works in process development and get it accepted for use in GMP manufacturing? That question stalls most bioprocess modeling projects before they start. Ignasi Bofarull-Manzano, Senior Data...

  • Episode #277

    277: Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins with Ignasi Bofarull-Manzano - Part 1

    Aug 11, 202627 min

    Most bioprocess teams believe a digital twin demands vast datasets and sophisticated models. Ignasi Bofarull-Manzano argues both assumptions are wrong, and that the data already sitting in your Excel files, historians...

  • Episode #276

    276: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 2

    Aug 6, 202618 min

    How do you turn a lab-born regenerative medical device into a solution that surgeons actually want to use and investors want to back? The path from academic innovation to clinical adoption is full of practical hurdles...

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