What Defines Excellence In CMC Analytics? A Conversation With Our Chief Scientific Officer

The difference between a CRO that simply processes samples and one that acts as a strategic partner can determine whether a program progresses smoothly or faces costly delays.

In this podcast, our Chief Scientific Officer, Daniel Galbraith, shares candid insights into what separates operational vendors from true scientific collaborators. His insights can save your program months of delays and costly missteps. Highlights include:

• Why cell and gene therapies face unique challenges compared to the progression seen with monoclonal antibodies (03:04)
• 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)