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

David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist
Biotechnology
Bioprocess Development
Bioprocessing
Biomanufacturing
Artificial Intelligence
Cell Therapy
Biologics Manufacturing
Cell and Gene Therapy
Gene Therapy
Cell Culture
Biologics
Drug Development
Continuous Manufacturing
Regulatory Compliance
Clinical Trials
Process Development
Biopharmaceutical Manufacturing
CMC Development
Biotech
Biopharmaceuticals

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 biom... more

PublishesTwice weeklyEpisodes259Founded3 years ago
Number of ListenersCategories
Life SciencesScience

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Artwork for Smart Biotech Scientist

Latest Episodes

What happens between scientific discovery and clinical trials? For too many drug candidates, the answer is “failure”—not because the idea lacked merit, but because the critical handoff between discovery and IND-enabling studies gets overlooked, rushe... more

The gap between a “drug” and a true “product” is where many therapies fail.

Milan Tomic, biotech veteran, GMP manufacturing expert, and founder of Albrem, has spent 30 years turning promising science into scalable, executable products that can actua... more

The "data lake" that was supposed to unify bioprocessing intelligence has, in most companies, become something else entirely: a data swamp, where information goes in and insight rarely comes back out. For anyone trying to deploy AI in GMP manufacturi... more

When AI can draft a literature review in minutes, the question bioprocess educators can no longer avoid is this: what does a student actually need to learn?

Steffen Kreye has a clear answer. As Professor of Industrial Biotechnology at Berliner Hochs... more

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Recent Guests

Milan Tomic
Founder/CEO of Albrem; experienced bioprocess developer and manufacturing leader
Albrem
Episode: 257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1
Steffen Kreye
Professor of industrial biotechnology
Berliner Hochschule für Technik (Berlin University of Applied Sciences)
Episode: 255: Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore with Steffen Kreye - Part 1
Yuta Lee
CEO of Accelerated Bio
Accelerated Bio
Episode: 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee - Part 2
Chantale Bernatchez
Head of process development at CTMC (Resilience and MD Anderson joint venture)
CTMC (Resilience + MD Anderson)
Episode: 249: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale Bernatchez - Part 1
Ron Najafi
Founder/CEO with decades in chemistry and biopharma
Emery Pharma (CRO) and NovaBay Pharmaceuticals
Episode: 247: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 1
Tibor Anderlei
Pioneered online monitoring and shake flasks; co-founded AC Biotech; leads customer success at Kühner Shaker
Kühner Shaker; AC Biotech
Episode: 245: Why Your Shake Flask Culture Doesn't Scale: OTR, Shaking Diameter, and How to Fix It with Tibor Anderlei - Part 1
Steve Oh
Leader in stem cell bioprocessing solutions, previously at ASTAR
ASTAR (Singapore)
Episode: 241: DMSO in Cell Therapy: Why Viability Scores Hide the Real Toxicity with Steve Oh - Part 1
Juergen Mairhofer
CEO of EnGenes Biotech
EnGenes Biotech
Episode: 240: Continuous Microbial Manufacturing: From Genetic Instability to 40-Day E. coli Processes with Juergen Mairhofer - Part 2
Sebastian Blum
Representative from Beckman Coulter, expert in BioLector systems
Beckman Coulter
Episode: 238: High-Throughput Microbial Screening: Avoiding Early Mistakes That Derail Scale-Up with Sebastian Blum - Part 2

Host

David Brühlmann
Host of Smart Biotech Scientist; CMC strategist and bioprocessing expert

Reviews

4.9 out of 5 stars from 30 ratings
  • Good stuff !

    I am enjoying this podcast and always learn a thing or two! Thanks David!

    Apple Podcasts
    5
    Rob78_13
    United States2 years ago
  • Insightful!

    I love my weekly dose of the Smart Biotech Scientist podcast! I enjoy hearing and learning from my peers in the biopharmaceutical development field, gaining new insights and perspectives on CMC development challenges, tech, and strategies. The host is knowledgeable and engaging, bringing expert guests who share their cutting-edge strategies and real-world experiences. Whether you’re a seasoned professional or new to the field, this podcast offers practical advice and innovative solutions that c... more

    Apple Podcasts
    5
    Giulia Lambiase
    United Kingdom2 years ago
  • Great interviews, good format

    David delivers a great podcasts: I like the depth of the conversations and also that the episodes have the perfect length for my commute to work👍

    Apple Podcasts
    5
    pilldipp
    Germany2 years ago
  • Deeply Refreshing Perspective

    I am really a fan of David’s content and his approach to intriguing subjects.

    Apple Podcasts
    5
    Stem Cell Guy
    United States3 years ago
  • Fantastic content!

    Great podcast! Highly recommend that anybody working in biotech listen to this podcast. David, the host, is very knowledgeable in the bio tech space. I have enjoyed the insights from the guests.

    Apple Podcasts
    5
    MatthiasV1976
    United States3 years ago

Listeners Say

Key themes from listener reviews, highlighting what works and what could be improved about the show.

Listeners praise deep, practical discussions and knowledgeable hosts.
Guests are high-caliber with actionable insights for biotech manufacturing and CMC.
The show consistently delivers engaging interviews with a clear focus on bioprocessing challenges and solutions.

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Talking Points

Recent interactions between the hosts and their guests.

258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 2
Q: How can listeners contact Milan or learn more about his work?
They can visit albrem.com or email Milan directly at milan@albrem.com; LinkedIn is also a good channel for connecting with him.
258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 2
Q: What is the number one takeaway Milan wants listeners to walk away with?
Stay curious and have fun; your curiosity drives learning and helps you navigate complex development challenges, while keeping the process enjoyable can sustain momentum and innovation.
258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 2
Q: What should a startup focus on first when facing limited resources and a tight timeline?
Prioritize understanding the target product profile and the essential CMC decisions that directly impact regulatory readiness, while designing experiments that test the molecule's key properties early. This means focusing on stability, solubility, and the necessary manufacturing steps that will most influence IND readiness, rather than chasing lower-priority optimizations.
255: Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore with Steffen Kreye - Part 1
Q: How is teaching evolving with AI and other new technologies, and what strategies have you implemented to prepare students for today's industry?
He explains moving from traditional lectures to a seminar-style format with active student engagement, prepares updated slides with current industry data, teaches hands-on lab work in bioreactors and cell culture, and emphasizes responsible AI use, including requiring citations for AI-assisted work and focusing on data interpretation and problem solving.
255: Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore with Steffen Kreye - Part 1
Q: Draw us into your story. Tell us what sparked your passion for biotech and what were some interesting stops along your way?
Steffen describes starting in biotechnology with a strong math and science foundation, progressing through academic and industry roles, and ultimately moving to academia to focus on teaching applied bioprocess engineering and collaborating with industry partners to keep curricula aligned with real-world needs.

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Frequently Asked Questions About Smart Biotech Scientist

What is Smart Biotech Scientist about and what kind of topics does it cover?

The show targets process development scientists and CMC leaders driving biologics into regulatory-ready therapies, with a practical, execution-focused angle on scale-up, tech transfer, GMP readiness, CDMO partnerships, and manufacturing economics. Episodes feature deep dives into cell therapy, bioprocess optimization, analytics, and regulatory strategy, often weaving in real-world practicalities, vendor and partner perspectives, and forward-looking tech like continuous manufacturing and digital twins. A standout aspect is the guest mix: senior industry practitioners and established biotech leaders share actionable frameworks, from SHAKe-scale decisions to complex CMC programs, making it a valuable resource for both hands-on engineers and bi... more

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Which podcasts are similar to Smart Biotech Scientist?

These podcasts share a similar audience with Smart Biotech Scientist:

1. Science Magazine Podcast
2. The McKinsey Podcast
3. The Ezra Klein Show
4. All-In with Chamath, Jason, Sacks & Friedberg
5. Decoder with Nilay Patel

How many episodes of Smart Biotech Scientist are there?

Smart Biotech Scientist launched 3 years ago and published 259 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on Smart Biotech Scientist?

Recent guests on Smart Biotech Scientist include:

1. Milan Tomic
2. Steffen Kreye
3. Yuta Lee
4. Chantale Bernatchez
5. Ron Najafi
6. Tibor Anderlei
7. Steve Oh
8. Juergen Mairhofer

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