Guidance for Industry: Characterization and qualification of cell substrates and other biological starting materials used in producing viral vaccines
by FDA Center for Biologics Evaluation and Research
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. In the guidance, FDA provides updated recommendations to the 1993 document "Points to Consider in the Characterization of Cell Lines Used to Produce Biologics." 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. It also provides information on testing at different stages of production and quality-control test methods for cell substrate and adventitious agent issues.
| Published: | 2006 |
| Format: | |
| Length: | 52 pages |
| Type: | White paper |
| Language: | English |
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