Literature DB >> 27452958

Impact of cell culture on recombinant monoclonal antibody product heterogeneity.

Hongcheng Liu1, Christine Nowak2, Mei Shao3, Gomathinayagam Ponniah2, Alyssa Neill2.   

Abstract

Recombinant monoclonal antibodies are commonly expressed in mammalian cell culture and purified by several steps of filtration and chromatography. The resulting high purity bulk drug substance still contains product variants differing in properties such as charge and size. Posttranslational modifications and degradations occurring during cell culture are the major sources of heterogeneity in bulk drug substance of recombinant monoclonal antibodies. The focus of the current review is the impact of cell culture conditions on the types and levels of various modifications and degradations of recombinant monoclonal antibodies. Understanding the relationship between cell culture and product variants can help to make consistently safe and efficacious products.
© 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1103-1112, 2016. © 2016 American Institute of Chemical Engineers.

Entities:  

Keywords:  cell culture; posttranslational modifications; recombinant monoclonal antibodies

Mesh：

Substances：

Year:  2016        PMID： 27452958     DOI： 10.1002/btpr.2327

Source DB:  PubMed          Journal:  Biotechnol Prog        ISSN： 1520-6033


  8 in total

1.  Comprehensive manipulation of glycosylation profiles across development scales.

Authors:  Sven Loebrich; Elisa Clark; Kristina Ladd; Stefani Takahashi; Anna Brousseau; Seth Kitchener; Robert Herbst; Thomas Ryll
Journal:  MAbs       Date:  2018-10-22       Impact factor: 5.857

Review 2.  Current advances in biopharmaceutical informatics: guidelines, impact and challenges in the computational developability assessment of antibody therapeutics.

Authors:  Rahul Khetan; Robin Curtis; Charlotte M Deane; Johannes Thorling Hadsund; Uddipan Kar; Konrad Krawczyk; Daisuke Kuroda; Sarah A Robinson; Pietro Sormanni; Kouhei Tsumoto; Jim Warwicker; Andrew C R Martin
Journal:  MAbs       Date:  2022 Jan-Dec       Impact factor: 5.857

3.  Investigation of anomalous charge variant profile reveals discrete pH-dependent conformations and conformation-dependent charge states within the CDR3 loop of a therapeutic mAb.

Authors:  Wenkui Lan; Joseph J Valente; Andrew Ilott; Naresh Chennamsetty; Zhihua Liu; Joseph M Rizzo; Aaron P Yamniuk; Difei Qiu; Holly M Shackman; Mark S Bolgar
Journal:  MAbs       Date:  2020 Jan-Dec       Impact factor: 5.857

4.  Improved process intermediate stability through the identification and elimination of reactive glycation residues - a monoclonal antibody case study.

Authors:  Allen Bosley; Kimberly Cook; Shihua Lin; David Robbins
Journal:  Bioengineered       Date:  2022-06       Impact factor: 6.832

Review 5.  The Different Colors of mAbs in Solution.

Authors:  Alexandre Ambrogelly
Journal:  Antibodies (Basel)       Date:  2021-05-24

Review 6.  Engineering of Fc Fragments with Optimized Physicochemical Properties Implying Improvement of Clinical Potentials for Fc-Based Therapeutics.

Authors:  Chunpeng Yang; Xinyu Gao; Rui Gong
Journal:  Front Immunol       Date:  2018-01-08       Impact factor: 7.561

7.  Sequence and Solution Effects on the Prevalence of d-Isomers Produced by Deamidation.

Authors:  Dylan L Riggs; Sonia V Gomez; Ryan R Julian
Journal:  ACS Chem Biol       Date:  2017-10-23       Impact factor: 5.100

8.  Analysis of Molecular Heterogeneity in Therapeutic IFNα2b from Different Manufacturers by LC/Q-TOF.

Authors:  Lei Yu; Lei Tao; Yinghua Zhao; Yonghong Li; Dening Pei; Chunming Rao
Journal:  Molecules       Date:  2020-08-31       Impact factor: 4.411
  8 in total

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