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
203: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 1
Finding an analytical CRO that's truly invested in your success, not just processing samples, makes all the difference in CMC development. In this episode, host David Brühlmann talks with Daniel Galbraith, Chief Scientific Officer at Solvias, about the essential questions and mindset that lead to breakthrough CRO partnerships.
With nearly three decades in analytical development, spanning monoclonal antibodies, biosimilars, and cell and gene therapies, Daniel reveals what separates CROs who become true partners from those who just run methods. His insights can save your program months of delays and costly missteps.
Key Topics Discussed:
- Why cell and gene therapies face unique challenges compared to the progression seen with monoclonal antibodies (03:04)
- Daniel’s career path: from entering biotech in 1996 to CSO at Solvias, and the rapid evolution of the industry (05:00)
- The analytical hurdles in characterizing cell-based products and how their inherent variability impacts development (09:46)
- Approaches to analytical method requirements for autologous cell therapies, and how data is gathered iteratively in these cases (13:02)
- The biggest obstacles to scaling up cell and gene therapies, and why innovative cell manipulation technologies are needed (16:06)
- Current trends in therapeutic modalities: why antibody-drug conjugates stand out, and whether mRNA therapies are losing momentum (18:37)
- Practical advice on choosing an analytical CRO as a strategic partner - what to look for, what questions to ask, and why enthusiasm and standardization matter (21:55)
Wondering how to streamline your own analytical strategy, or navigate the parallel universe of cell and gene therapy development? Dig into this episode for Daniel’s insider perspective. Then consider how the right analytical partnership could accelerate your path to clinic.
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