DRAFT

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

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

OPEN SESSION
AVAILABLE IN THE PUBLIC DIOMAIN —

DRAFT

Introduction
CBER is requesting expert advice from the Vaccines and Related BiologicalProducts Advisory Committee (VRBPAC) upon the use of Vero cells for the production of viral vaccines. To provide you with information upon which to consider your feedback, confidential information aboutproducts under review in Investigational New Drug Applications (INDs) has been provided to you under separate cover. In addition, below you will find a summary about the published history andcharacterization of Vero cells, as well as a brief description of the tests recommended by 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 International Conference on Harmonisation (ICH) Q5D document entitled “Guidance on Quality ofBiotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products” published in the Federal Register on 9/21/98.Currently, the Vero cell line is used to produce only one U.S. licensed viral vaccine, inactivated poliovirus vaccine produced by Aventis Pasteur. However, CBER has received proposals either in pre-lNDor under IND to use Vero cells to produce many other viral vaccines, including live viral vaccines. With the exception of this one licensed inactivated and purified vaccine, all other licensed vaccinesare produced in diploid cell strains (WI-38, MRC-5, FRhL-2), yeast, or prinnary cells (eggs, primary monkey kidney cells) which are considered “normal.” In contrast, the Vero cell line is a... [continua]

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