Literature DB >> 17161664

Process analytics for purification of monoclonal antibodies.

Stephen Flatman1, Imtiaz Alam, Jeffery Gerard, Nesredin Mussa.   

Abstract

The application of appropriate analytical methods is an essential requirement for the purification of therapeutic antibodies. A range of analytical methods need to be employed to effectively determine the purity, identity, integrity and activity of these important class of pharmaceuticals. These include notably electrophoresis, high performance liquid chromatography and immunoassays. Regulatory and industry demands in recent years have brought the need for improvements and many have been successfully implemented. This article reviews the current analytical methods applied to support the purification of monoclonal antibodies.

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Year:  2006        PMID: 17161664     DOI: 10.1016/j.jchromb.2006.11.018

Source DB:  PubMed          Journal:  J Chromatogr B Analyt Technol Biomed Life Sci        ISSN: 1570-0232            Impact factor:   3.205


  8 in total

1.  Rapid quantitative analysis of monoclonal antibody heavy and light chain charge heterogeneity.

Authors:  Ram P Vanam; Michael A Schneider; Michael S Marlow
Journal:  MAbs       Date:  2015-08-25       Impact factor: 5.857

2.  Structural characterization of IgG1 mAb aggregates and particles generated under various stress conditions.

Authors:  Srivalli N Telikepalli; Ozan S Kumru; Cavan Kalonia; Reza Esfandiary; Sangeeta B Joshi; C Russell Middaugh; David B Volkin
Journal:  J Pharm Sci       Date:  2014-01-22       Impact factor: 3.534

Review 3.  Bridging the gap: facilities and technologies for development of early stage therapeutic mAb candidates.

Authors:  Trent P Munro; Stephen M Mahler; Edwin P Huang; David Y Chin; Peter P Gray
Journal:  MAbs       Date:  2011-09-01       Impact factor: 5.857

4.  Development of a fibrinogen-specific sandwich enzyme-linked immunosorbent assay microarray assay for distinguishing between blood plasma and serum samples.

Authors:  Rachel M Gonzalez; Qibin Zhang; Richard C Zangar; Richard D Smith; Thomas O Metz
Journal:  Anal Biochem       Date:  2011-03-01       Impact factor: 3.365

5.  Gemcitabine-loaded PLGA-PEG immunonanoparticles for targeted chemotherapy of pancreatic cancer.

Authors:  Sahil Aggarwal; Swati Gupta; Dilrose Pabla; R S R Murthy
Journal:  Cancer Nanotechnol       Date:  2013-09-24

6.  In-column ATR-FTIR spectroscopy to monitor affinity chromatography purification of monoclonal antibodies.

Authors:  Maxime Boulet-Audet; Sergei G Kazarian; Bernadette Byrne
Journal:  Sci Rep       Date:  2016-07-29       Impact factor: 4.379

7.  Real-time monitoring and model-based prediction of purity and quantity during a chromatographic capture of fibroblast growth factor 2.

Authors:  Dominik Georg Sauer; Michael Melcher; Magdalena Mosor; Nicole Walch; Matthias Berkemeyer; Theresa Scharl-Hirsch; Friedrich Leisch; Alois Jungbauer; Astrid Dürauer
Journal:  Biotechnol Bioeng       Date:  2019-04-17       Impact factor: 4.530

8.  Differential response in downstream processing of CHO cells grown under mild hypothermic conditions.

Authors:  Andrew S Tait; Richard D R Tarrant; M Lourdes Velez-Suberbie; Daniel I R Spencer; Daniel G Bracewell
Journal:  Biotechnol Prog       Date:  2013-05-02
  8 in total

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