Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
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Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
Listen Score
LS 28
Global Rank
TOP 10%

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 biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readiness


  • You are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutiny


  • You are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resources


What you will learn:


CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling, manufacturing economics, continuous manufacturing, digitization, and Industry 4.0 in biopharma.


Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide.


New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up.


Next Steps:


Get the 5-day CMC email course: https://smartbiotechscientist.com/#cmc


Visit the website: https://smartbiotechscientist.com


Email us: hello@bruehlmann-consulting.com

Science
Life Sciences
Hosts:
Update frequency:
semiweekly
Average audio length:
20 minutes
Guest interviews
Has sponsors
English
United States
297 episodes
since Oct. 31, 2023
episodic
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IN THIS PODCAST 🔗

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LATEST EPISODE 🔗

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

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

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 atherosclerotic plaque with therapies designed to actively reverse disease, not simp…
00:20:39
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PREVIOUS EPISODES

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

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

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 Affairs at Cyclarity Therapeutics, is developing a drug that sits between a…
00:25:02
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294: Is CFD Overkill for Your Scale-Up? Why It Belongs in Every Biotech Scientist's Toolkit with Christian Witz - Part 2

294: Is CFD Overkill for Your Scale-Up? Why It Belongs in Every Biotech Scientist's Toolkit with Christian Witz - Part 2

Scale-up doesn't fail because the science was wrong. It fails because a cell's environment in a shake flask has little in common with its environment in a bioreactor. Christian Witz has spent years building the tools to close that gap: simulating exactly what a cell experiences as it move…
00:22:09
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293: Is CFD Overkill for Your Scale-Up? Why It Belongs in Every Biotech Scientist's Toolkit with Christian Witz - Part 1

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

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 months of delay to patients waiting on a therapy. Christian Witz believes th…
00:22:57
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292: The Fool's Game That Became Standard Practice: Perfusion, the ATF, and What Changed with John Bonham-Carter - Part 2

292: The Fool's Game That Became Standard Practice: Perfusion, the ATF, and What Changed with John Bonham-Carter - Part 2

Biotech founders often pour everything into building the “perfect” product only to realize their real customers have walked out the door. Chasing perfection can burn money and stall even the most promising CMC innovations. In this episode, David Brühlmann continues his conversation with biotech ent…
00:22:25
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291: The Fool's Game That Became Standard Practice: Perfusion, the ATF, and What Changed with John Bonham-Carter - Part 1

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

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 intensification through perfusion—now the backbone of leading biomanufactu…
00:30:36
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290: Batch-to-Batch Variability Is a Design Failure, Not the Norm with Sandra Núñez - Part 2

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

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. She’s challenging the status quo as CEO of Amela Biosciences by running a “virtu…
00:20:04
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289: Batch-to-Batch Variability Is a Design Failure, Not the Norm with Sandra Núñez - Part 1

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

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 eliminate. Drawing on 15 years across Lonza, Medinova, Baxalta, and Biogen, she’s engin…
00:19:26
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288: Why the Cell Line Is the CMC Decision You Don't Get to Undo with Sigma Mostafa - Part 2

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

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 Mostafa, Chief Scientific and Technology Officer at KBI Biopharma. Sigma brings dee…
00:21:45
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287: Why the Cell Line Is the CMC Decision You Don't Get to Undo with Sigma Mostafa - Part 1

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

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 development get kicked down the road. On the Smart Biotech Scientist Podcast, David Br…
00:18:10
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Disclaimer: The podcast and artwork embedded on this page are from David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist, which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.
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