Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
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:
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
244: Prevent the Delays That Derail Biologics Tech Transfer: 12-Week Protocol for CMC
Use Left/Right to seek, Home/End to jump to start or end. Hold shift to jump forward or backward.
When a single mismanaged tech transfer threatens an entire development program, pressure on CMC leaders and bioprocess teams is intense. The truth? Tech transfers aren’t a black box. They’re complex, but solvable with the right mindset and playbook.
In this episode, David Brühlmann explores the practical side of tech transfer and scale-up within the biotech industry. With more than 15 years of experience, he shares personal stories and industry-tested frameworks that help demystify the complexities of transferring technologies between sites or organizations. Instead of focusing solely on technical details, he emphasizes the crucial human and organizational factors that often decide project success or failure.
Key topics discussed:
- How mapping and managing stakeholders can resolve hidden issues and accelerate projects (01:55)
- Case studies highlighting the importance of environmental factors — like light exposure — in process performance and troubleshooting (05:50)
- A mass transfer checklist for bioprocess scale-up, with specific focus on equipment-related parameters (07:09)
- The build vs. outsource dilemma: how to choose what to keep in-house and what to partner out, depending on company strategy and project phase (08:05)
- A 12-week tech transfer preparation protocol, covering foundations, risk mitigation, and execution readiness (10:16)
- Lessons on leadership, prioritization, and effective delegation to avoid personal and organizational bottlenecks (13:28)
Whether you're overseeing a complex CMC program, navigating CDMO relationships, or planning your next scale-up, this episode offers concrete steps to cut through confusion and deliver results.
If you’re interested in the ideas discussed, here are some of the guests David referenced in this episode.
- Episodes 91 - 92: Mass Transfer Secrets: Mastering Bubbles and kLa from Bench to Large-Scale Production with Lars Puiman & Rik Volger
- Episodes 79 - 80: Think Before You Build: Holistic Approaches to Biotech Facility Design with Alfredo Martínez Mogarra
- Episodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias Müllner
- Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene Lee