The N-mAb case study brought together over 60 industry and government stakeholders from over 20 organizations to develop shared expectations and vocabulary around a control strategy for an integrated continuous bioprocess for a hypothetical monoclonal antibody. This document presents a starting place for conversations within organizations around implementing continuous integrated bioprocesses in commercial manufacturing.
National Institute for Innovation in Manufacturing Biopharmaceuticals. 2022. N-mAb: A case study to support development and adoption of integrated continuous bioprocesses for monoclonal antibodies. Version 1. N-mab.org. Download Date.
NIIMBL collaborated with the Alliance for Regenerative Medicine (ARM) on two case studies related to integrating Quality by Design (QbD) principles into cell and gene therapy programs:
Case study-based approach to integrating QbD principles into gene therapy Chemistry, Manufacturing, and Controls (CMC) programs
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