NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Well ATLnsider, it seems to me that the best way to handle the logistical issues with a cell therapy is to first remove any time constraints by cryopreserving the leukapheresis material, which I’m pretty sure will be the case. I’ve posted before that I think it makes sense to have regional manufacturing regardless, so when the time comes for commercial manufacturing, I believe Northwest Bio will contract with Advent at Sawston to manufacture for the UK and EU, while Charles Rivers Labs will manufacture for the US and Canada. The closest model that I know of for the commercialization of a cell therapy is KITE/Gilead, and that’s exactly what they did (regional manufacturing) even with cryopreserved leukapheresis material.

I’m not sure if anyone else noticed this language in the latest Q:

Manufacturing Services Agreements
Advent BioServices
On November 8, 2019, the Company and Advent entered into an Ancillary Services Agreement with an 8-month Term for U.K. Facility Development Activities and Compassionate Use Program Activities. The Ancillary Services Agreement establishes a structure under which Advent develops Statements of Work (“SOWs”) for the U.K. Facility Development Activities and Compassionate Use Program Activities, and delivers those SOWs to the Company for review and approval. After an SOW is approved by the Company, Advent will proceed with or continue the applicable services and will invoice the Company pursuant to the SOW. Since both the U.K. Facility Development and the Compassionate Use Program involve pioneering and uncertainties in most aspects, the invoicing under the Ancillary Services Agreement is on the basis of costs incurred plus fifteen percent. The Ancillary Services Agreement had an original term of eight months, which ended in July 2020. The Company extended the term by 12 months to July 2021, with no other changes, and recently extended it for another 12 months to July 2022.

So, it appears that the development activities with Advent at Sawston won’t be completed for a while . . . cryopreserved leukapheresis material equivalency studies?

As far as the Flaskworks’ comparability studies, this is what I’ve previously said:
“Northwest Biotherapeutics has an ancillary services agreement with Advent Bioservices to oversee the construction and development of the Sawston manufacturing facility, which includes testing the Flaskworks system and developing an automated process. Milestones in the Flaskworks Purchase Agreement require that the Flaskworks’ technical team assist Advent Bioservices for the deployment and comparability studies of the Flaskworks’ system, as well as the preparation of the necessary documentation for submission to the regulatory agencies in the UK, US, Canada and EU. Nowhere in this agreement does it state that Cognate, Charles Rivers Labs, or UCLA will be conducting any validation activities with the Flaskworks’ system, and I’m not sure why so many posters on this board continue to perpetuate this notion.”