Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in Producing Viral Vaccines


The U.S. Food and Drug Administration (FDA) on Sept. 28, 2006 issued new guidance to aid manufacturers in developing safe and effective cell-based viral vaccines. The updated guidance conveys information for determining the suitability of a cell culture for manufacturing, as well as testing and validating the safety and purity of the cells used in the development and production of viral vaccines.

Author: FDA Center for Biologics Evaluation and Research  | File Type: PDF

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