Cole Kevin P, Johnson Martin D
a Small Molecule Design and Development , Eli Lilly and Company , Indianapolis , IN , USA.
Expert Rev Clin Pharmacol. 2018 Jan;11(1):5-13. doi: 10.1080/17512433.2018.1413936. Epub 2017 Dec 15.
For the manufacture of small molecule drugs, many pharmaceutical innovator companies have recently invested in continuous processing, which can offer significant technical and economic advantages over traditional batch methodology. This Expert Review will describe the reasons for this interest as well as many considerations and challenges that exist today concerning continuous manufacturing. Areas covered: Continuous processing is defined and many reasons for its adoption are described. The current state of continuous drug substance manufacturing within the pharmaceutical industry is summarized. Current key challenges to implementation of continuous manufacturing are highlighted, and an outlook provided regarding the prospects for continuous within the industry. Expert commentary: Continuous processing at Lilly has been a journey that started with the need for increased safety and capability. Over twelve years the original small, dedicated group has grown to more than 100 Lilly employees in discovery, development, quality, manufacturing, and regulatory designing in continuous drug substance processing. Recently we have focused on linked continuous unit operations for the purpose of all-at-once pharmaceutical manufacturing, but the technical and business drivers that existed in the very beginning for stand-alone continuous unit operations in hybrid processes have persisted, which merits investment in both approaches.
对于小分子药物的制造，许多制药创新公司最近都投资于连续加工，与传统的批次生产方法相比，连续加工具有显著的技术和经济优势。本专家评论将阐述引发这种兴趣的原因，以及当前在连续制造方面存在的诸多考量因素和挑战。涵盖领域：定义了连续加工，并描述了采用它的诸多原因。总结了制药行业内连续原料药制造的现状。突出了当前连续制造实施过程中的关键挑战，并对该行业内连续制造的前景给出了展望。专家评论：礼来公司的连续加工历程始于对提高安全性和生产能力的需求。在过去的十二年里，最初的小型专业团队已发展壮大，礼来公司在连续原料药加工的发现、开发、质量、制造和监管设计等方面拥有超过100名员工。最近，我们专注于用于一次性药物制造的联动连续单元操作，但混合工艺中独立连续单元操作最初存在的技术和商业驱动因素依然存在，这使得对这两种方法都值得投资。
