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Cell line for manufacturing of DC vaccine

Contribution from Daniela Rozkova written on 9/16/2008 at 15:38

Hi,
can anyone give me basic information about what is needed/required to start with a clinical trial using allogeneic cells line for manufacturing cell-based medicinal product (DC vaccine)? Which guidelines, directives are relevant for us? We used cell lines in our preclinical experiments, but for the trial we need them in GMP quality. Is it possible to purchase them somewhere and what is the price? Please if you have any experience with this problem, let me know.
Thank you!
Daniela Rozkova, Prague, Czech Republic

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