Cell Substrates for Biologics Production: Factors Affecting Acceptability
At the present time, the viral vaccines licensed for use in humans in the United States are produced in cells derived from a wide variety of sources. Table 1 shows the specific cell system for each vaccine and the year in which the vaccine was licensed. To some degree the cell type used for a given vaccine reflects the available technology at the time of licensure, and the then current consensus on what constituted an acceptable cell source. The classic example, of course, is poliovirus vaccine. Primary rhesus monkey kidney cultures were used initially. With the discovery of SV-40 as a rhesus agent capable of contaminating the vaccine, primary African green monkey kidney cell culture became the substrate of choice. More recently, diploid cells of human origin have been used to produce poliovirus vaccine, thus introducing an alternate acceptable cell substrate for vaccine production. Because new data have been developed at a rapid rate over the past decade in the biological sciences, and because there has been a large experience with cells from a variety of sources in vaccine production, it is of interest to examine which criteria are of major importance in assessing the acceptability of cells. The purpose of this discussion is to review those major criteria of acceptability which have been applied to cells used in biologics production up to the present time, and to critically analyze the logic and reasonableness of those criteria in the context of the general knowlege that is currently available in the biological sciences as well as the general experience with vaccines produced in a variety of cell types. The focus will be on cell lines rather than on both cell lines and primary cultures, since the use of primary cultures will be covered in depth by Dr. Parks, and I am sure that during the course of this symposium there will be many opportunities for us to discuss the issues relating to primary cell cultures.
KeywordsBiologics Production Diploid Cell Primary Cell Culture Vaccine Production Cell Substrate
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