An Integrated Process Analytical Technology (PAT) Approach to Monitoring the Effect of Supercooling on Lyophilization Product and Process Parameters of Model Monoclonal Antibody Formulations

David Awotwe−Otoo; Cyrus Agarabi; Mansoor A. Khan

doi:10.1002/jps.24005

An Integrated Process Analytical Technology (PAT) Approach to Monitoring the Effect of Supercooling on Lyophilization Product and Process Parameters of Model Monoclonal Antibody Formulations

Journal of Pharmaceutical Sciences ◽

10.1002/jps.24005 ◽

2014 ◽

Vol 103 (7) ◽

pp. 2042-2052 ◽

Cited By ~ 14

Author(s):

David Awotwe−Otoo ◽

Cyrus Agarabi ◽

Mansoor A. Khan

Keyword(s):

Monoclonal Antibody ◽

Process Parameters ◽

Process Analytical Technology ◽

Integrated Process ◽

Product And Process ◽

Analytical Technology

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Real-Time Monitoring and Controlling of Lyophilization Process Parameters through Process Analytical Technology Tools

PAT Applied in Biopharmaceutical Process Development And Manufacturing ◽

10.1201/b11536-18 ◽

2011 ◽

pp. 269-298

Keyword(s):

Real Time ◽

Process Parameters ◽

Process Analytical Technology ◽

Real Time Monitoring ◽

Technology Tools ◽

Analytical Technology

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Quality-by-Design: An Integrated Process Analytical Technology Approach to Determine the Nucleation and Growth Mechanisms During a Dynamic Pharmaceutical Coprecipitation Process

Journal of Pharmaceutical Sciences ◽

10.1002/jps.22430 ◽

2011 ◽

Vol 100 (5) ◽

pp. 1969-1986 ◽

Cited By ~ 12

Author(s):

Huiquan Wu ◽

Mansoor A. Khan

Keyword(s):

Quality By Design ◽

Process Analytical Technology ◽

Nucleation And Growth ◽

Integrated Process ◽

Growth Mechanisms ◽

Coprecipitation Process ◽

Nucleation And Growth Mechanisms ◽

Analytical Technology

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Integrated Process Analytical Technology Approach for Nucleation Induction Time Measurement and Nucleation Mechanism Assessment for a Dynamic Multicomponent Pharmaceutical Antisolvent Crystallization System

Industrial & Engineering Chemistry Research ◽

10.1021/ie4036466 ◽

2014 ◽

Vol 53 (4) ◽

pp. 1688-1701 ◽

Cited By ~ 9

Author(s):

Huiquan Wu ◽

Maury White ◽

Robert Berendt ◽

Ryan D. Foringer ◽

Mansoor Khan

Keyword(s):

Induction Time ◽

Process Analytical Technology ◽

Time Measurement ◽

Nucleation Mechanism ◽

Integrated Process ◽

Crystallization System ◽

Antisolvent Crystallization ◽

Analytical Technology

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Strategic Vision for Integrated Process Analytical Technology and Advanced Control in Biologics Manufacturing

PAT Applied in Biopharmaceutical Process Development And Manufacturing ◽

10.1201/b11536-7 ◽

2011 ◽

pp. 37-56 ◽

Cited By ~ 1

Keyword(s):

Process Analytical Technology ◽

Integrated Process ◽

Strategic Vision ◽

Advanced Control ◽

Analytical Technology

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Process Analytical Technology in Continuous Processing: Model-based real time control of pH between capture chromatography and viral inactivation for monoclonal antibody production

Journal of Chromatography A ◽

10.1016/j.chroma.2021.462614 ◽

2021 ◽

pp. 462614

Author(s):

Garima Thakur ◽

Pragati Ghumade ◽

Anurag S. Rathore

Keyword(s):

Monoclonal Antibody ◽

Real Time ◽

Antibody Production ◽

Process Analytical Technology ◽

Continuous Processing ◽

Real Time Control ◽

Viral Inactivation ◽

Monoclonal Antibody Production ◽

Time Control ◽

Analytical Technology

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An Integrated Process Analytical Technology (PAT) Approach for Pharmaceutical Crystallization Process Understanding to Ensure Product Quality and Safety: FDA Scientist’s Perspective

Organic Process Research & Development ◽

10.1021/op500056a ◽

2014 ◽

Vol 19 (1) ◽

pp. 89-101 ◽

Cited By ~ 22

Author(s):

Huiquan Wu ◽

Zedong Dong ◽

Haitao Li ◽

Mansoor Khan

Keyword(s):

Product Quality ◽

Crystallization Process ◽

Process Analytical Technology ◽

Quality And Safety ◽

Integrated Process ◽

Process Understanding ◽

Product Quality And Safety ◽

Analytical Technology ◽

Ensure Product Quality

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Strategic Vision for Integrated Process Analytical Technology and Advanced Control in Biologics Manufacturing

PAT Applied in Biopharmaceutical Process Development And Manufacturing - Biotechnology and Bioprocessing ◽

10.1201/b11536-3 ◽

2011 ◽

pp. 9-28

Author(s):

Melissa St. Amand ◽

Peter Millili ◽

Meghan McCabe ◽

Babatunde Ogunnaike

Keyword(s):

Process Analytical Technology ◽

Integrated Process ◽

Strategic Vision ◽

Advanced Control ◽

Analytical Technology

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Quality-by-Design (QbD): An integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and process design space development☆

International Journal of Pharmaceutics ◽

10.1016/j.ijpharm.2010.11.045 ◽

2011 ◽

Vol 405 (1-2) ◽

pp. 63-78 ◽

Cited By ~ 57

Author(s):

Huiquan Wu ◽

Maury White ◽

Mansoor A. Khan

Keyword(s):

Process Design ◽

Quality By Design ◽

Design Space ◽

Process Analytical Technology ◽

Precipitation Process ◽

Integrated Process ◽

Process Characterization ◽

Co Precipitation ◽

Analytical Technology

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On-Line Ion Exchange Liquid Chromatography as a Process Analytical Technology for Monoclonal Antibody Characterization in Continuous Bioprocessing

Analytical Chemistry ◽

10.1021/acs.analchem.7b02228 ◽

2017 ◽

Vol 89 (21) ◽

pp. 11357-11365 ◽

Cited By ~ 19

Author(s):

Bhumit A. Patel ◽

Nuno D.S. Pinto ◽

Adrian Gospodarek ◽

Bruce Kilgore ◽

Kudrat Goswami ◽

...

Keyword(s):

Monoclonal Antibody ◽

Liquid Chromatography ◽

Ion Exchange ◽

Process Analytical Technology ◽

On Line ◽

Analytical Technology ◽

Monoclonal Antibody Characterization

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Quality‐by‐Design (QbD): An Integrated Process Analytical Technology (PAT) Approach for Real‐Time Monitoring and Mapping the State of a Pharmaceutical Coprecipitation Process

Journal of Pharmaceutical Sciences ◽

10.1002/jps.21923 ◽

2010 ◽

Vol 99 (3) ◽

pp. 1516-1534 ◽

Cited By ~ 34

Author(s):

Huiquan Wu ◽

Mansoor A. Khan

Keyword(s):

Real Time ◽

Quality By Design ◽

Process Analytical Technology ◽

The State ◽

Integrated Process ◽

Real Time Monitoring ◽

Coprecipitation Process ◽

Analytical Technology

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