Abstract：
In this chapter, we discuss production requirements for therapeutic bacteriophage preparations. We review the current regulatory expectancies and focus on pragmatic production processes, implementing relevant controls to ensure the quality, safety, and efficacy of the final products. The information disclosed in this chapter can also serve as a basis for discussions with competent authorities regarding the implementation of expedited bacteriophage product development and licensing pathways, taking into account some peculiarities of bacteriophages (as compared to conventional medicines), such as their specificity for, and co-evolution with, their bacterial hosts. To maximize the potential of bacteriophages as natural controllers of bacterial populations, the implemented regulatory frameworks and manufacturing processes should not only cater to defined bacteriophage products. But, they should also facilitate personalized approaches in which bacteriophages are selected ad hoc and even trained to target the patient\'s infecting bacterial strain(s), whether or not in combination with other antimicrobials such as antibiotics.
摘要：
在这一章中,我们讨论了治疗性噬菌体制剂的生产要求。我们回顾了当前的监管预期，并专注于务实的生产流程，实施相关控制以确保质量，安全,和最终产品的功效。本章披露的信息也可以作为与主管当局讨论实施快速噬菌体产品开发和许可途径的基础，考虑到噬菌体的一些特点（与常规药物相比），例如它们的特异性，和共同进化，它们的细菌宿主。为了最大限度地发挥噬菌体作为细菌种群的天然控制者的潜力，实施的监管框架和制造过程不仅应满足定义的噬菌体产品。但是,他们还应该促进个性化的方法，在这些方法中，噬菌体被临时选择，甚至被训练为针对患者的感染细菌菌株，无论是否与其他抗生素如抗生素联合使用。
