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no2koolaid

01/08/23 11:10 AM

#557702 RE: flipper44 #557697

flip, the question is not whether something can be done logistically, but whether it can be done without adding costs. It comes down to more than mere supply chain questions and is about the value chain and its activities-based-costing.

A value chain is a step-by-step business model for transforming a product or service from idea to reality. Value chains help increase a business's efficiency so the business can deliver the most value for the least possible cost.

hyperopia

01/09/23 11:21 AM

#557964 RE: flipper44 #557697

That’s a reasonable suggestion flipper, but it’s been my observation that, while Dave serves a valuable purpose, he’s been unable to answer seemingly immaterial questions in a direct manner, so I haven’t talked with him in a couple years. In this case, it could reveal a commercialization strategy.

I thought that Northwest Bio was planning a slow (go-it alone) commercialization rollout only in the UK this year to work out the commercialization kinks, and then later next year expand to the US. Using fresh monocytes, and regional manufacturing would be fine for this type of commercial startup. However, if Linda is taking about global distribution, and redundant manufacturing, possibly implying a much larger commercial rollout, (potentially with a strategic partner say for Project Orbis) then cryopreserving leukapheresis material would absolutely be necessary. Let’s hope that Advent has been working on this since before I first raised the issue in 2021.

By the way, the first approved CAR-T manufacturers (Kite & Novartis) both cryopreserved their leukapheresis material early in clinical trial development, in recognition of the eventual logistical necessity for global distribution.