Introduction to N-mAb

The N-mAb case study was produced by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) as a learning tool for both industry and regulators around adoption of advanced manufacturing process technologies such as integrated continuous bioprocesses (ICB) for mAbs, following the model of the A-mAb case study with a similar goals of stimulating discussion and advancing new concepts. The N mAb webinar will present two major ICB process options along with the evolution of an integrated control strategy starting from early clinical manufacturing as process understanding increases from process design through process characterization and validation including a discussion of the challenges involved in managing quality in real time.

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