Sterilization of Polymeric Implants: Challenges and Opportunities.
Sterilization of Polymeric Implants: Challenges and Opportunities.
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DOI：
10.1021/acsabm.2c00793
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发表时间：
2022-11-21
影响因子：
4.7
通讯作者：
Song J
中科院分区：
文献类型：
--
作者：
Herczeg CK;Song J
可降解和环境响应型聚合物已被积极开发用于药物输送和再生医学应用，但对其与最终灭菌的兼容性考虑不足，给临床转化带来了显着障碍。这篇综述讨论了行业建立的最终灭菌方法和无菌加工，并将它们与旨在保持聚合物植入物完整性的创新方法进行了对比。讨论了监管指南、财政考虑因素和潜在陷阱，以鼓励在材料设计中尽早整合无菌监管考虑因素。
Degradable and environmentally responsive polymers have been actively developed for drug delivery and regenerative medicine applications, yet inadequate consideration of their compatibility with terminal sterilization presents notable barriers to clinical translation. This review discusses industry-established terminal sterilization methods and aseptic processing and contrasts them with innovative approaches aimed at preserving the integrity of polymeric implants. Regulatory guidelines, fiscal considerations, and potential pitfalls are discussed to encourage early integration of sterility regulatory considerations in material designs.