Amgen Inc., Thousand Oaks, California, USA.
Purification Process Sciences, AstraZeneca, Gaithersburg, Maryland, USA.
Biotechnol Prog. 2024 Mar-Apr;40(2):e3414. doi: 10.1002/btpr.3414. Epub 2023 Nov 28.
The N-mAb case study was produced by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to support teaching and learning for both industry and regulators around adoption of advanced manufacturing process technologies such as integrated continuous bioprocesses (ICB) for monoclonal antibodies (mAbs). N-mAb presents the evolution of an integrated control strategy, from early clinical through process validation and commercial manufacturing with a focus on elements that are unique to ICB. The entire N-mAb case study is quite comprehensive, therefore this publication presents a summary of the chapter on managing deviations from a state of control in real time. This topic is of critical importance to ICB and is also applicable to batch processes operated at a rapid cadence.
N-mAb 案例研究由国家制造创新研究所（NIIMBL）制作，旨在支持行业和监管机构围绕采用先进的制造工艺技术（如单克隆抗体 (mAb) 的集成连续生物工艺 (ICB)）进行教学和学习。N-mAb 展示了集成控制策略的演变，从早期临床到工艺验证和商业生产，重点关注 ICB 所特有的要素。整个 N-mAb 案例研究非常全面，因此本出版物总结了关于实时管理控制状态偏差的一章。这个主题对 ICB 至关重要，也适用于快速节拍运行的批处理过程。
