I am requesting this information on behalf of a small biotechnology
company that is in the Phase I stage of a drug development. Human
epithelial cell line and animal serum derived products are used in the
process. We need to develop test methods for virus testing of the cell
line, bulk and virus clearance testing of the purified bulk to meet the
FDA guidance on "Q5A Viral safety evaluation of Biotechnology products
derived from cell lines of Human or Animal origin"
We will appreciate any help the members can provide on appropriate
viruses that need to be tested, test methods and references to any
laboratories that perform these types of assays.
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