As recently as a few years ago, the discussions we were having about how to scale cell and gene therapies (CGTs) primarily centered on whether manufacturing could keep up with demand. At the time, that was a real constraint. Process development was still evolving, and it wasn’t uncommon for tech transfer to take longer than expected. Frequently, available capacity didn’t align with the reality of clinical timelines. Programs would stall, but for reasons that were easy to point to. 

That type of constraint still exists today, but it’s no longer the primary constraint determining how quickly (or cleanly) a program moves forward once it reaches later-stage development. Manufacturing can usually be addressed with investment and time, but what proves harder to correct is the end-to-end supply chain that surrounds it. 

As programs grow from pre-clinical development into clinical trials and toward commercialization, the work spreads across a wider network of sites and systems. Some of those systems sit within…