FDA Releases Final Guidance on Characterization of Cell Substrates and Bio Materials for Viral Vaccines

March 3, 2010

FDA has released finalized, nonbinding guidance on the characterization and qualification of cell substrates and biologicial materials used in the production of viral vaccines.

A critical section for manufacturers regards testing at different stages of production, from cell banks and pre-production cells to final filled product. The guidance also contains descriptions of test methods for adventitious agents and cell properties.

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