VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

May 11-12, 2000

Briefing Information

History and Characterization of the Vero Cell Line, CDR Rebecca Sheets, PhD, FDA .pdf

Draft of Points to Consider in the Characterization of Cell lines Used to Produce Biologicals (1993) .pdf

International Conference on Harmonisation; Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of biotechnological/Biological Products, Federal Register Notice, September 21, 1998, 63FR50244 .pdf .txt

International Conference on Harmonisation; Guidance on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Federal Register Notice, September 24, 1998, 63FR51074, .pdf .txt

Bibliography of Articles .rtf .pdf