Adventitious agents in viral vaccines: Lessons learned from 4 case studies

Author:

Petricciani John,Sheets Rebecca,Griffiths Elwyn,Knezevic Ivana

Funder

Library of Congress

U.S. National Library of Medicine

Institute for Biological Products Control

National Institutes for Food and Drug Control

Center for Biologics Research and Evaluation

U.S. Food and Drug Administration

European Medicines Agency

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference56 articles.

1. Regulatory risk evaluation on finding an adventitious agent in a marketed vaccine: scientific principles to consider. http://www.who.int/biologicals.

2. Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks. Replacement of TRS 878,2013

3. The induction of neoplasms with a substance released from mouse tumors by tissue culture;Stewart;Virology,1957

4. Neoplasms in hamster induced by mouse tumor agent passed in tissue culture;Eddy;J Natl Cancer Inst,1958

5. Hearings before the subcommittee on executive reorganization and government research of the committee on government operations,1972

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