Insmed Inc., 10 Finderne Ave, Bridgewater, NJ, US.
Department of Biochemical Engineering, University College London, Gordon Street, London, WC1H 0AH, UK.
Biotechnol J. 2019 Feb;14(2):e1700740. doi: 10.1002/biot.201700740. Epub 2018 Jun 11.
Over the last several years, continuous manufacturing of pharmaceuticals has evolved from bulk APIs and solid oral dosages into the more complex realm of biologics. The development of continuous downstream processing techniques has allowed biologics manufacturing to realize the benefits (e.g., improved economics, more consistent quality) that come with continuous processing. If relevant processing techniques and principles are selected, the opportunity arises to develop continuous manufacturing designs for additional pharmaceutical products including liposomal drug formulations. Liposome manufacturing has some inherent aspects that make it favorable for a continuous process. Other aspects such as formulation refinement, materials of construction, and aseptic processing need development, but present an achievable challenge. This paper reviews the current state of continuous manufacturing technology applicable to liposomal drug product manufacturing and an assessment of the challenges and potential of this application.
在过去的几年中，药物的连续制造已经从原料药和固体制剂发展到更复杂的生物制剂领域。连续下游加工技术的发展使得生物制药制造能够实现连续加工带来的好处（例如，提高经济性、更一致的质量）。如果选择了相关的加工技术和原理，就有机会为其他药物产品（包括脂质体药物制剂）开发连续制造设计。脂质体制备具有一些内在的方面，使其有利于连续工艺。其他方面，如配方细化、材料构建和无菌处理需要开发，但这是一个可实现的挑战。本文综述了适用于脂质体药物产品制造的连续制造技术的现状，并评估了该应用的挑战和潜力。
