
Tuesday, May 30, 2023 1:15:14 PM
I thought the DCVax was produced in the UCLA lab for the trial
https://clinicaltrials.gov/ct2/show/NCT00045968
Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. Patients must also have sufficient DCVax-L product available after manufacturing. These determinations will be made by Cognate BioServices, Inc. (Cognate) and communicated to the clinical site through the Sponsor, or its designee.
and
https://www.prnewswire.com/news-releases/nw-bio-announces-settlement-with-cognate-bioservices-resolving-past-matters-and-providing-for-restart-of-dcvax-direct-production-300857384.html
If you believe that there is less risk in building a CDMO specialized in manufacturing and developing cell therapy from scratch then there is, at least until some years after approval, working together with Charles River Labs a company with 21,400 employees and highly specialized in products and services to help expedite the discovery, early-stage development and safe manufacture of novel cell therapy drugs and therapeutics. And if you believe CRL would have been eager to butch this up and mess up its reputation as the go-to partner for biotech companies, then you do you.
Also, you still have not explained to me why in 2023 CRL is good enough according to LP at the ASM but was not right after data lock?
And I dont know why ImmunityBio messed up their manufacturing with their third-party CDMO but there is no other nonrevenue biotech company in the world ever that finances the private CDMO for their CEO instate of outsourcing the drug production to a partner such as CRL.
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