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Re: The Danish Dude post# 677810

Monday, 03/11/2024 2:14:32 PM

Monday, March 11, 2024 2:14:32 PM

Post# of 698763
On Flaskworks not needing a comparability study, what can I say. Anybody knows this is needed for a major process change and NWBO says it is.

On you sig line, ATL-DC vs DC-L try this:

ATl_DC is made with one batch per dose, per the combo trial paper pre-print

One day before each vaccination, DC were pulsed (co-cultured) with tumor lysate overnight, washed, and the final product was tested for sterility by Gram stain, mycoplasma and endotoxin testing prior to injection



DCVax-L is made with a single batch with all forzen for future use per the latest 10K (and hundreds of other cites).

Both of these technologies, the personalized batch manufacturing for each patient and the cryopreservation, are essential elements of our manufacturing model and product economics. Together, they enable us to usually incur the high costs of manufacturing just one time for each patient, and then store the multi-year or multi-dose quantity of product, frozen, in single doses.

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