Moving science from bench to clinic can be done either in-house or at a CDMO. It’s the breadth and width of experience that a CDMO brings to the table that’s critical to success. Are they working with your supplier to really know how to tweak a process to fit into what you’re trying to build?
If you must change critical process parameters later in Phase II, it can change your entire product profile. And that could result in a much higher failure rate. It’s important to focus on making sure you’re optimized early on and ready for scale-up. Here, experts in the cell and gene therapy field share their hard-won experiences.