Sanofi, Purification Development-Mammalian Platform, Framingham, Massachusetts, USA.
Biogen, Biologics Development, Biogen, Research Triangle Park, North Carolina, USA.
Biotechnol Prog. 2024 Jul-Aug;40(4):e3425. doi: 10.1002/btpr.3425. Epub 2024 Jan 30.
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 to accelerate adoption of advanced manufacturing process technologies such as integrated continuous bioprocesses (ICB) for mAbs. Similar to the A-mAb case study, 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 integrated continuous bioprocesses. This publication presents a summary of the process design and characterization chapters to allow a greater focus on the unique elements relevant to that phase of development.
N-mAb 案例研究由国家制造生物制药创新研究所（NIIMBL）制作，旨在支持行业的教学和学习，并加速采用先进的制造工艺技术，如单克隆抗体的集成连续生物工艺（ICB）。与 A-mAb 案例研究类似，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制造，重点关注集成连续生物工艺特有的要素。本出版物总结了工艺设计和表征章节，以便更关注与该开发阶段相关的独特要素。
