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Related Experiment Video

Updated: Jun 11, 2026

Continuous Flow Chemistry: Reaction of Diphenyldiazomethane with p-Nitrobenzoic Acid

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Published on: November 15, 2017

Process development and characterization for integrated continuous bioprocesses-Highlights from N-mAb.

Kevin Brower¹, Kelly Wiltberger², Claudia Berdugo³

¹Sanofi, Purification Development-Mammalian Platform, Framingham, Massachusetts, USA.

Biotechnology Progress

|January 30, 2024

Summary

This summary is machine-generated.

This case study details the N-monoclonal antibody (mAb) process, focusing on integrated continuous bioprocesses (ICB) and control strategies from development to commercial manufacturing. It highlights unique aspects of ICB for mAb production.

Keywords:

integrated continuous bioprocessing integrated process characterization integrated process design perfusion risk assessment

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Area of Science:

Biopharmaceutical Manufacturing
Chemical Engineering
Process Control

Background:

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) developed the N-mAb case study.
Industry adoption of advanced manufacturing technologies like integrated continuous bioprocesses (ICB) requires effective teaching and learning tools.
Previous case studies, such as A-mAb, have explored similar concepts.

Purpose of the Study:

To support education and training in biopharmaceutical manufacturing.
To accelerate the adoption of integrated continuous bioprocesses (ICB) for monoclonal antibody (mAb) production.
To present the evolution of an integrated control strategy for ICB, focusing on unique elements.

Main Methods:

The N-mAb case study summarizes process design and characterization chapters.
It focuses on elements unique to integrated continuous bioprocesses (ICB).
The study traces the development of an integrated control strategy through various manufacturing stages.

Main Results:

The N-mAb case study provides a framework for understanding ICB for mAbs.
It details the progression of control strategies from early clinical phases to commercial manufacturing.
Unique aspects of ICB relevant to process design and characterization are highlighted.

Conclusions:

The N-mAb case study serves as a valuable educational resource for biopharmaceutical manufacturing.
It emphasizes the importance of integrated control strategies in advanced manufacturing processes.
Focusing on unique elements of ICB aids in accelerating technology adoption.