NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

biosectinvestor, it would be a change of the established conditions. I’m not sure what part of the trial you are describing, (actually UCLA has their own version and protocols) however, once there are regulatory approved manufacturing protocols, it would be necessary to conduct a comparability study for a new manufacturing site, and this was done when the trial included Fraunhofer manufacturing.

Again, I’m unaware of the regs you are describing, but they are evolving, and there are some aspects of demonstrating comparability which are unique for cell therapy such as variability and scarcity of cellular source materials. This is why I believe that Advent will use split manufacturing, where a single lot of source material is divided and processed in parallel with both the prechange and postchange processes. This absolutely, can not be done across different labs. There is another method to demonstrate comparability where the post-change process would be compared to historical lots, but this isn’t the preferred method, and obviously wouldn’t be possible at Sawston.

I’ve had this discussion with others who said that the Flaskworks comparability study could be done at Advent’s London lab. It could, but that would require another comparability study to transfer the protocol to another site such as Sawston. This is why NW Bio announced the Flaskworks prototype was delivered to Sawston and the practice runs will be performed at Sawston, because the Flaskworks system will be tested and used at Sawston.

Come to think of it, I posted some links which may be helpful in that post here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167133951