Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders
The go-to CMC and bioprocessing podcast for process development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.
Practical, execution-focused guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics.
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 and manufacturing economics, continuous manufacturing and Industry 4.0 in biopharma, biologics modalities including mAbs, ADCs, and cell and gene therapies.
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:
Book a free assessment to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/assessment
Fast-track bioprocess development with expert guidance: https://bruehlmann-consulting.com
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders
204: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 2
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Cell and gene therapies are transforming modern medicine, but their path to market is fast and complex. They often jump from small trials to global launch at record speed, putting pressure on analytics, supply chains, and partnerships. Success depends on making smart choices about what to build in-house and what to entrust to expert partners.
Daniel Galbraith knows these challenges intimately. With decades of hands-on experience and as Chief Scientific Officer at Solvias, Daniel has witnessed firsthand the seismic shifts in analytical development for advanced therapies. He’s been on every side of the table: troubleshooting manufacturing snags, scaling up from a single batch to hundreds per month, and guiding companies as they choose between in-house development and relying on a CRO’s muscle.
In this episode:
- How evolving cell and gene therapy timelines are driving the need for true CRO-drug developer partnerships (00:00)
- The unique challenges of scaling CMC analytics from early trials to global commercialization (02:51)
- Key pitfalls to avoid when outsourcing to CROs—especially around communication, scheduling, and troubleshooting (06:26)
- Deciding whether to build capabilities in-house or outsource to a CRO, and how to find the right balance for your team (08:41)
- The critical importance of strong project management for juggling relationships between developer, CRO, and CDMO (09:51)
- Daniel's perspective on the future of combination therapies and what the analytical landscape will demand of CROs (13:33)
- Practical advice for building transparent, open CRO partnerships that support your goals (15:21)
Facing scale-up challenges or a first CGT launch? This conversation shares practical strategies to advance therapies efficiently.
Tune in for actionable insights on CMC, outsourcing, and analytical development.
Connect with Daniel Galbraith:
LinkedIn: www.linkedin.com/in/daniel-galbraith-26a6138
Solvias website: www.solvias.com
Email: daniel.galbraith@solvias.com
Next steps:
Need fast CMC guidance? New on-demand CMC advisory: Get 20 expert answers/month in 1 day + monthly strategy call. → Learn more: https://stan.store/SmartBiotech/p/ondemand-cmc-expertise-for-biotech-founders
Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
Preparing for your IND? Grab our Startup Founder CMC Dashboard in Notion to help you track tasks, timelines, and risks in one place at https://stan.store/SmartBiotech/p/discovertoind-cmc-dashboard-for-startup-founders
One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.