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An overview of animal cell substrates for biological products
Authors:John Petricciani  Rebecca Sheets  
Institution:aJohn Wayne Cancer Institute, 2200 Santa Monica Boulevard, Santa Monica, CA 90404, USA;bCaptain, U.S. Public Health Service, NIH/NIAID, Room 5145, 6700B Rockledge Drive, MSC-7628, Bethesda, MD 20892-7628, USA
Abstract:The issue of which cells to use as substrates for the production of biological products, and especially vaccines, has been with us in one form or another ever since the development of cell cultures in the 1950s.The major cell substrate events that occurred over the past 50 years are reviewed briefly. Although numerous conferences were held during that period, incomplete resolution of some cell substrate issues has remained. Specifically, the potential oncogenicity of cellular DNA derived from continuous cell lines, and the tests that are used to rule out the presence of adventitious agents have been recognized as areas that could benefit greatly from studies using state-of-the-art techniques.A collaborative effort involving WHO, NIAID, and IABS resulted from consensus recommendations of a 2004 conference, and the prospects for revised guidance in the near future on the characterization and use of animal cell substrates are bright.
Keywords:Cell substrates  Vaccines  Biological products
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