DRAFT

History and Characterization of the Vero Cell Line
A Report prepared by CDR Rebecca Sheets, Ph. D., USPHSCBEFVOVRFVDVRPANVB

for the Vaccines and Related Biological Products Advisory Committee Meeting to be held on May 12,2000

OPENSESSION
AVAILABLE IN THE PUBLIC DIOMAIN —

DRAFT

Introduction
CBER is requesting expert advice from the Vaccines andRelated Biological Products Advisory Committee (VRBPAC) upon the use of Vero cells for the production of viral vaccines. Toprovide you with information upon which to consider your feedback, confidential information about products under review inInvestigational New Drug Applications (INDs) has been provided to you under separate cover. In addition, below you will find asummary about the published history and characterization of Vero cells, as well as a brief description of the tests recommendedby CBER for characterization of cell lines used to produce biological, as promulgated in the 1993 “Points to Consider in theCharacterization of Cell Substrates Used to Produce 13iologicals” (referred to herein as the PTC) and the InternationalConference on Harmonisation (ICH) Q5D document entitled “Guidance on Quality of Biotechnological/Biological Products: Derivation [continua]

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