Balancing Innovation With Manufacturability When GMP-Grade Is Unavailable

Some raw materials simply aren't available in GMP. Experts Yan Zhi and Lawrence Thompson describe risk assessment approaches that inform sourcing decisions in this segment from Cell & Gene Live "Viability On The Line." Some investigational therapies require many unique raw materials, and controlling them appropriately gets tricky. Complexities also vary by modality and batch size. Control strategies must be adaptable.

Our guests address whether innovation's pace should slow down until we have a more robust raw material supply chain.