Laboratory of Pharmaceutical Technology, Ghent University.
Laboratory of Pharmaceutical Technology, Ghent University.
Int J Pharm. 2020 Apr 15;579:119194. doi: 10.1016/j.ijpharm.2020.119194. Epub 2020 Mar 2.
Continuous drug product manufacturing is slowly being implemented in the pharmaceutical industry. Although the benefits related to the quality and cost of continuous manufacturing are widely recognized, several challenges hampered the widespread introduction of continuous manufacturing of drug products. Current review presents an overview of state-of-the art research, equipment, process analytical technology implementations and advanced control strategies. Additionally, guidelines and regulatory viewpoints on implementation of continuous manufacturing in the pharmaceutical industry are discussed.
连续药品制造正在制药行业中逐步得到实施。尽管连续制造在质量和成本方面的优势得到了广泛认可，但仍存在一些挑战阻碍了药品连续制造的广泛应用。本综述介绍了最新的研究、设备、过程分析技术实施和先进控制策略的概述。此外，还讨论了制药行业中连续制造实施的指南和监管观点。
