Overcoming challenges of improving legacy biopharmaceutical processes. Issue 5 (8th March 2021)

• Record Type: Journal Article
• Authors: Gao, Ying; Gervais, David
• Is Part Of: Journal of chemical technology & biotechnology. Volume 96:Issue 5(2021)
• Page Start: 1141
• Page End: 1150
• Publication Date: 2021-03-08
• Subjects: legacy biopharmaceutical process -- process improvement strategy -- product and process characterisation -- regulatory constraints; Biotechnology -- Periodicals; Chemistry, Technical -- Periodicals; Chemical engineering -- Periodicals; Industries -- Environmental aspects -- Periodicals; 660
• DOI: 10.1002/jctb.6687
• Languages: English
• ISSNs: 0268-2575

Abstract

Abstract: 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).