Abstract
We will attempt to give an overview of the developments in the use of various cell substrates for the production of viral vaccines that has led to the present thinking of the regulatory agency of the United States, the Division of Biologics Standards (DBS), concerning such substrates. As such, it is a synthesis of information previously presented by many others and, also, of data derived from studies performed by others under contract funds from DBS. It is hoped in this way to make you aware of the practicalities that face a regulatory agency in the decision-making processes.
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Kirschstein, R., Petricciani, J.C. (1972). Viral Vaccines: Various Cell Substrates and Long-Term Prospective Studies. In: Kohn, A., Klingberg, M.A. (eds) Immunity in Viral and Rickettsial Diseases. Advances in Experimental Medicine and Biology, vol 31. Springer, Boston, MA. https://doi.org/10.1007/978-1-4684-3225-1_15
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DOI: https://doi.org/10.1007/978-1-4684-3225-1_15
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