Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
The Go-to Podcast for Biotech Scientists Who Want to Master Biopharma CMC Development and Biomanufacturing.
**TOP 10 LIFE SCIENCES PODCAST**
Are you ready to simplify bioprocess development and scale with confidence to reduce time to market?
Are you feeling overwhelmed by the complexity and guesswork of biologics development and biomanufacturing?
Do you wish you had more time to enjoy the beauty of science, without worrying about failing your cell culture process development and commercialization?
There's a way to simplify and streamline so you can remove complexity, skip trials and errors, deliver your groundbreaking therapy to clinics and market without delay, and still enjoy every single step.
I'm David Brühlmann, a biotech entrepreneur and strategic advisor who partners with C-level biopharma leaders to tackle one of our industry's biggest challenges: reducing manufacturing costs to make lifesaving therapies accessible to more patients worldwide.
Through engaging conversations with industry pioneers and practical insights from the trenches, this podcast tackles the critical challenges in bioprocess CMC development and manufacturing of recombinant proteins and cell and gene therapy products. We cut through the complexity so you can:
- Master bioprocess development with confidence and clarity
- Excel at scale-up and manufacturing of biologics
- Transform your innovative therapy and manufacturing technology into market-ready solutions faster
- Optimize manufacturing costs without compromising quality
- Make data-driven decisions that reduce the risk of failure
I can’t wait to help you do biotech the smart way.
Grab a cup of coffee and your favorite notebook and pen. Now is the time to take your bioprocessing game to the next level.
Ready to transform your biomanufacturing journey? Let's dive in!
Next Steps:
Book a free call to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/call
🧬 Ready to accelerate your IND timeline? Get the proven CMC Dashboard that's guided successful mAb programs from chaos to submission: https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders
Accelerate biologics development with expert guidance: https://bruehlmann-consulting.com
For sponsorship opportunities, contact us at hello@bruehlmann-consulting.com
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
204: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 2
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 step:
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
🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-round