NorthWest Biotherapeutics Inc (NWBO)

[dmb2]

hyperopia, I am familiar with Terumo company but not this filling system. I would be most focused on the Flaskworks as the guts of the mfg process, but as you know if every step is not done right there could be critical failures. I have been involved with major fill/finish installations but never worked with systems this modest in scale, I never encountered personalized processing, only larger batch processing. It would be a great assignment to work on this though.

Most BP's have installed SAP as their MES but as you probably also know there are several good alternatives, especially for smaller operations. Good thing these steps and this processing equipment is small scale, but, as you note when you include all NWBO is concurrently doing it is significant and easy to lose time along the way. Today's RA's will require a level of automation that will not allow much contamination risk, and any step highlighted as such in a process risk analysis will require a high set of procedures to protect it and a tight set of tests to monitor it.

The Advent team needs to be good, and so far they have passed muster with their GMP certification. Thx again for the process commentary.

GLTA