Wahlich John
Academy of Pharmaceutical Sciences, c/o Bionow, Greenheys Business Centre, Manchester Science Park, Pencroft Way, Manchester M15 6JJ, UK.
Pharmaceutics. 2021 Aug 22;13(8):1311. doi: 10.3390/pharmaceutics13081311.
Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuously fed into and transformed, and the processed output materials are continuously removed from the system. CM can be considered as matching the FDA's so-called 'Desired State' of pharmaceutical manufacturing in the twenty-first century as discussed in their 2004 publication on 'Innovation and Continuous Improvement in Pharmaceutical Manufacturing'. Yet, focused attention on CM did not really start until 2014, and the first product manufactured by CM was only approved in 2015. This review describes some of the benefits and challenges of introducing a CM process with a particular focus on small molecule solid oral dosage forms. The review is a useful introduction for individuals wishing to learn more about CM.
连续制造（CM）被定义为一种过程，在该过程中，输入物料被连续送入并进行转化，经过加工的输出物料则被连续从系统中移除。连续制造可被视为符合美国食品药品监督管理局（FDA）在其2004年关于“制药制造中的创新与持续改进”的出版物中所讨论的21世纪制药制造的所谓“理想状态”。然而，对连续制造的重点关注直到2014年才真正开始，并且通过连续制造生产的首个产品直到2015年才获得批准。本综述描述了引入连续制造工艺的一些益处和挑战，特别侧重于小分子固体口服剂型。该综述对于希望更多了解连续制造的个人而言是一份有用的入门介绍。
