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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. 

N-mAb Case Study

N-mAb Poster Presentation

How to cite N-mAb

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. Download Date.

Project A-Gene and Project A-Cell

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:

Project A-Gene

Case study-based approach to integrating QbD principles into gene therapy Chemistry, Manufacturing, and Controls (CMC) programs

Project A-Cell

Incorporating QbD principles into a manufacturing case study of a Chimeric Antigen Receptor T-cell (CAR-T) therapy

Project Highlights

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