Continuous process improvement of biopharmaceutical processes is an expectation of the current regulatory environment (e.g. ICH Q8 and Q10), and extends to older products as well as new licences. Particularly in the case of older products, process changes are also often simply required to improve process efficiency, to facilitate easier manufacture and to update materials such as chromatography resins and filters that may become unavailable due to age. These older processes, or legacy processes, present unique challenges for process improvement. This paper discusses the challenges and strategies of implementing changes and new technologies for improving legacy manufacturing processes, and outlines the issues to be addressed during process redevelopment and validation, including product and process characterisation and particular regulatory constraints to ensure product profile and quality are maintained when making process changes. Case studies are presented, with a focus on adaptation of single‐use technologies for commercial biopharmaceutical processes. © 2021 Society of Chemical Industry (SCI).

中文翻译：

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克服改善传统生物制药工艺的挑战

对生物制药过程的持续过程改进是当前监管环境（例如ICH Q8和Q10）的期望，并且扩展到旧产品和新许可证。特别是在较旧产品的情况下，通常也仅需要简单地进行过程更改，以提高过程效率，简化制造过程并更新可能会因使用年限而变得无法使用的材料，例如色谱树脂和过滤器。这些较旧的流程或旧流程对流程改进提出了独特的挑战。本文讨论了实施变更和新技术以改善传统制造流程的挑战和策略，并概述了在流程重建和验证过程中要解决的问题，包括产品和过程的特性描述以及特定的法规限制，以确保在进行过程更改时保持产品资料和质量。本文介绍了案例研究，重点是将一次性技术应用于商业生物制药过程。©2021化学工业协会（SCI）。