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.

中文翻译：

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噬菌体生产中的噬菌体：与其他疗法或食品相比，风险被高估了吗？

与其他使用化学药品和灭活的或活的生物制剂的治疗方法相比，在西方国家，作为生活和复制性生物治疗剂的溶菌性噬菌体的康复只有2年的历史。本文试图提供从法规角度解决噬菌体药物制剂中前噬菌体含量问题的论据。作者比较了（i）与各种治疗性抗感染治疗以及食品或益生菌中所含的溶原性噬菌体和噬菌体相比，（ii）与不定形的完整逆转录病毒或疫苗中包含的片段，以及（iii）抗生素使用引起的溶原性噬菌体和原噬菌体的大量释放。