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Biological product manufacturing standards

Executive Summary

FDA issues final rule establishing general requirements for cell lines used for manufacturing any biological product for human use. The rule, in the Dec. 10 Federal Register, requires manufacturers to describe in their applications the tumorigenic potential of a cell line. Since the general requirements apply to all biological products, the specific requirements for poliovirus vaccine live oral under an existing regulation are no longer necessary. FDA notes that the requirements do not pertain to primary cell cultures that are not subcultivated and primary cell cultures that are subcultivated for only a very limited number of population doublings.
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