The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.

中文翻译：

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制药工艺开发和制造中的连续制造。

制药业发现了将连续加工用于制造当前正在开发的新疗法的新应用。监管机构鼓励这种转型，并受到成本降低，开发周期缩短，批量使用不可行的新化学方法的访问，安全性提高，生产平台灵活以及产品质量保证提高的推动。从批处理到连续制造过程的转换是此审查的重点。本文仅限于化学合成的小有机分子，涵盖了活性药物成分（API）和后续药物产品的生产。连续药物产品目前用于批准的过程中。