符合监管要求的菌体生产
Jean-Paul Pirnay1, Maia Merabishvili2, Daniel De Vos2
1Laboratory for Molecular and Cellular Technology, Queen Astrid Military Hospital, Brussels, Belgium. Jean-Paul.Pirnay@mil.be.
Methods in molecular biology (Clifton, N.J.)
|December 8, 2023
概括
本章概述了治疗性菌体制剂的生产要求,重点关注质量,安全性和有效性. 它探讨了针对细菌治疗的定义和个性化细菌治疗的调节途径,以对抗细菌感染.
科学领域:
- 微生物学 微生物学
- 生物技术是生物技术.
- 监管科学 监管科学
背景情况:
- 治疗性菌体为控制细菌感染提供了抗生素的有希望的替代品.
- 目前的制造工艺和监管框架需要对菌体制剂进行调整.
- 菌体表现出独特的特征,包括宿主特异性和共同进化,需要量身定制的生产和监管方法.
结论:
- 优化生产流程和适应性监管框架对于成功的细菌治疗的临床实施至关重要.
- 未来的战略应该包括个性化的菌体方法,以有效地准各种细菌感染.
- 菌体治疗具有作为细菌性疾病的补充或替代治疗的巨大潜力.
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