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
.pdfDraft of Points to Consider in the Characterization of Cell lines Used to Produce Biologicals (1993)
.pdfInternational 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 .txtInternational 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 .txtBibliography of Articles
.rtf .pdf