Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies

Author:

Chopda Viki1,Gyorgypal Aron1ORCID,Yang Ou2,Singh Ravendra1ORCID,Ramachandran Rohit1,Zhang Haoran1,Tsilomelekis George1,Chundawat Shishir P S1ORCID,Ierapetritou Marianthi G2

Affiliation:

1. Department of Chemical and Biochemical Engineering Rutgers, The State University of New Jersey Piscataway NJ USA

2. Department of Chemical and Biomolecular Engineering University of Delaware Newark DE USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Inorganic Chemistry,Organic Chemistry,Pollution,Waste Management and Disposal,Fuel Technology,Renewable Energy, Sustainability and the Environment,General Chemical Engineering,Biotechnology

Reference181 articles.

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4. FDA Center for Drug Evaluation and Research.Guidance for industry PAT ‐ a framework for innovative pharmaceutical development manufacturing and quality assurance (Docket No. FDA‐2003‐D‐0032). Available:https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/pat‐framework‐innovative‐pharmaceutical‐development‐manufacturing‐and‐quality‐assurance(2004).

5. Process Analytical Technology (PAT): Batch-to-batch reproducibility of fermentation processes by robust process operational design and control

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