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

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