Replies to post #239457 on NorthWest Biotherapeutics Inc (NWBO)

[sukus]

I agree that they are very challenging. I also agree with your conclusion.


https://www.genengnews.com/insights/scaling-up-cell-therapy-manufacturing/

GEN: Are there currently any regulatory hurdles that slow the cell therapy scale-up progression, and how are manufacturers dealing with them?

Dr. Adams: The biggest regulatory hurdle relates to the overall understanding of our processes by the entire industry. Because we are still in the early days of developing and commercializing these therapies, we have a tremendous amount to learn about process behavior and the real relationships between product quality attributes and clinical safety and efficacy. As such, we all over-sample and over-test our products to collect as much data as possible to get at those questions.