Automated Online-Sampling Multidimensional Liquid Chromatography with Feedback-Control Capability as a Framework for Real-Time Monitoring of mAb Critical Quality Attributes in Multiple Bioreactors

Author:

Dunn Zachary D.1ORCID,Bohman Patrick2,Quinteros Alexis3,Sauerborn Brian4,Milman Felix4,Patel Misaal3,Kargupta Roli3,Wu Suyang3,Hornshaw Martin2,Barrientos Rodell1,Bones Jonathan56ORCID,Tayi Venkata S.3,Abaroa Nicholas4,Patel Bhumit1ORCID,Appiah-Amponsah Emmanuel1,Regalado Erik L.1ORCID

Affiliation:

1. Analytical Research and Development, MRL, Merck & Co., Inc., Rahway, New Jersey 07065, United States

2. Thermo Fisher Scientific, 168 Third Avenue, Waltham, Massachusetts 02451, United States

3. Process Research and Development, MRL, Merck & Co., Inc., Rahway, New Jersey 07065, United States

4. Engineering, MRL, Merck & Co., Inc., Rahway, New Jersey 07065, United States

5. The National Institute for Bioprocessing Research and Training, Foster Avenue, Mount Merrion, Blackrock, Co., Dublin A94 X099, Ireland

6. School of Chemical and Bioprocess Engineering, University College Dublin, Belfield, Dublin 4 D04 V1W8, Ireland

Publisher

American Chemical Society (ACS)

Subject

Analytical Chemistry

Reference35 articles.

1. Implementation of Near-Infrared Spectroscopy for In-Line Monitoring of a Dehydration Reaction in a Tubular Laminar Reactor

2. Integrated Process Analytical Platform for Automated Monitoring of Monoclonal Antibody N-Linked Glycosylation

3. A common framework for integrated and continuous biomanufacturing

4. Guidance for Industry PAT─A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), Food and Drug Administration, Center for Drug Evaluation and Research: 5600 Fishers Lane, Rockville, MD, 2004.

5. Assessment of Recent Process Analytical Technology (PAT) Trends: A Multiauthor Review

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