RE: Cell line for manufacturing of DC vaccine Contribution from Roy Cowell written on 9/16/2008 at 20:01
Original contribution: Cell line for manufacturing of DC vaccine written by Daniela Rozkova on 9/16/2008 at 15:38) Those details you require are to be found in the ICH Q5 series of documents. Establishment of a Master Cell Bank to cGMP is the starting point. ATCC (American Tissue Culture Collection) is a source of accredited cell lines, however thier suitability should be judged on a risk basis taking account of cell line history and safety testing. Prior approval from the competent authority maybe advisable before manufacture of clinical materials.
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