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Re: longfellow95 post# 296901

Monday, 07/27/2020 6:35:07 AM

Monday, July 27, 2020 6:35:07 AM

Post# of 704072
Longfellow, I think the shelf-life has been validated up to five years. Maybe you don’t remember this presentation at Phacilitate Immunotherapy World, January 26, 2015:



Slide min. 21:40

DCVax-L: Cost-Effective, Rapid Batch Manufacturing.

DAY 1: Tumor tissue & blood at manufacturing facility
DAY 2 : Precursors of dendritic cells isolated
DAY 2-7: Precursors differentiated into dendritic cells
DAY 7: Dendritic cells “educated to exposure to biomarkers from tumor tissue
DAY 8: “Educated “ dendritic cells harvested & frozen. Manufacturing finished. (Release tests follow)
Single manufacturing run yields 3-5 years of doses of DCVAX-L product. Only 2 grams of tumor tissue needed for full batch. With < 2 grams of tumor tissue, a partial batch can be produced.

we’ve spent 10 years working on that. We validated the frozen shelf life and potency to the satisfaction of regulators in three countries, the USA, Germany and UK, and it is a very practical product. We only ever do manufacturing once per patient. We manufacture three to five years worth of doses in that eight days manufacturing run.”
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