Close this search box.


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

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
NIIMBL-BioPhorum Buffer Stock Blending System

Become a member

We offer a variety of membership options that give you the flexibility to choose your organization’s level of engagement based on technology interests and priorities.

View / Download N-mAb Case Study

Download the N-mAb Case Study PDF

View / Download N-mAb Poster Presentation

Download the N-mAb Poster Presentation

Join Our Mailing List

MailChimp NIIMBL Mailing List Signup
Organization Type
How did you first hear about NIIMBL?