Automated instant labeling chemistry workflow for real-time monitoring of monoclonal antibody N-glycosylation

Author:

Gyorgypal Aron12ORCID,Potter Oscar G.3,Chaturvedi Antash1,Powers David N.2ORCID,Chundawat Shishir P. S.1ORCID

Affiliation:

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

2. Center for Drug Evaluation and Research, Office of Product Quality, Office of Biotechnology Products, Division of Biotechnology Review and Research II, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA

3. Agilent Technologies, Inc., 5301 Stevens Creek Blvd, Santa Clara, California, USA

Abstract

Integration of Instant Procainamide (Instant-PC) flow chemistry into the N-GLYcanyzer PAT sequential injection system enables automated real-time monitoring of mAb N-glycosylation dynamics to facilitate advanced biologics manufacturing processes.

Funder

U.S. Food and Drug Administration

Oak Ridge Associated Universities

Agilent Technologies

National Institute for Innovation in Manufacturing Biopharmaceuticals

National Institute of Standards and Technology

Publisher

Royal Society of Chemistry (RSC)

Subject

Fluid Flow and Transfer Processes,Process Chemistry and Technology,Chemical Engineering (miscellaneous),Chemistry (miscellaneous),Catalysis

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