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. N-mab.org. 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
Workforce Expansion in Biomanufacturing Emerging Technologies
Modularized PAT Online Training Platform to Accelerate the Workforce Innovation in Biopharmaceuticals Manufacturing
WORDE: A Biopharmaceutical Training Center to Promote Development of the Workforce, Outreach, Research, Diversity, and Education
International Assessment of PSPT in Mice to Replace the Intracerebral-challenge Mouse Protection Test (MPT) for Whole-cell Pertussis (wP)
A Multivariate In-Line Optochemical Sensor Platform for Continuous Monitoring of Cross-Category Process Parameters and Product Attributes in Bioreactors
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