| Summary: | The rehabilitation of lytic bacteriophages, as living and replicative biological therapeutic agents, is only 2 decades old in western countries, compared to other therapeutic approaches using chemicals and inactivated or alive biologicals. This paper attempts to provide arguments to address prophage content issues in phage pharmaceutical preparations from a regulatory perspective. The author rebalances the risk associated with the presence of prophages in their pharmaceutical preparations in comparison (i) to lysogenic phages and prophages contained in various therapeutic anti-infective treatments, as well as in food or probiotics, (ii) to adventitious whole retroviruses or fragments contained in vaccines, and (iii) to the massive release of lysogenic phages and prophages induced by antibiotics usage.
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