NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

This post is to clarify an earlier post I made here. A friend who reads the board, and watched the ASCO presentation multiple times, was pretty adamant that Shashi Murthy said there was more comparability work to do, (as flipper also noted) so he asked me to clarify how Flaskworks could be part of the commercial license application for Sawston if the comparability study wasn’t completed prior to the application. So I more carefully watched the ASCO presentation for a third time, and agree that Sashi Murthy did say that some comparability work still needed to be done. This however, doesn’t change my thesis that the Flaskworks Eden system is a part of the commercial license application

When I initially watched the ASCO presentation, I was pretty certain that Advent had completed all of the required qualification work (DQ, IQ, OQ, PQ) for the Flaskworks system, and likely most of the validation work for the entire commercial automated process. This would have been a prerequisite for the comparability study, but there wasn’t enough information in that presentation to determine exactly where Advent was in the Flaskworks’ comparability process. (As I’ve posted previously, this type of change protocol likely requires months to prepare and then submit to regulators for their pre-approval, which could take a couple more months)

Qualification is a process of assurance that specific system(s), premises or equipment are able to achieve predetermined acceptance criteria to confirm the attributes what it purports to do. It is the means of providing documented evidence that a specific piece of equipment, facility or system is fit/ready for intended use. In contrast to qualification, validation applies to processes and procedures. Validation is intended to demonstrate in a documented form, that the processes, methods, tests, activities and equipment they deploy are capable of repeatedly producing the desired product. Therefore, each critical step in the manufacturing process must be verified to perform as intended under defined conditions. This validation is required for commercial GMP manufacturing.

When Advent announced the following month that it was filing for the commercial license, and had installed seven new pieces of automated equipment for the manufacturing process, I was confident that Flaskworks was a part of the application, which basically confirmed (to me) that all of the required qualification steps, and automated process validation work according to the Validation Master Plan, had indeed been completed. Although I initially thought the comparability study may have been conducted prior to the submittal of the license application, I don’t believe it’s necessary for the commercial manufacturing license. The Flaskworks Eden system just needed to be qualified and validated, which I believe it was.

The comparability study is required to show regulators that the DCVax “product” is the same after the change(s) in the manufacturing process, as it was prior to the change(s). If the Flaskworks comparability study wasn’t completed before July, Advent could have applied for the commercial license in July, and meanwhile, conduct the comparability study during the summer. Then the CP and analysis could be submitted later (sometime in the past couple of months) so approval of the CP and Flaskworks automated process could be approximately concurrent with the approval of the commercial manufacturing license. Depending on when the marketing application is/was submitted, the CP could be submitted with it, or after it as a post approval supplement.

The mechanics of the Flaskworks’ approval process is actually irrelevant to my overall thesis that the automated process using the Flaskworks system will be used from the get-go when Northwest Bio begins commercialization and negotiates insurance reimbursement. I believe this was always the plan.