Literature DB >> 29513619

Analytical comparability study of recombinant monoclonal antibody therapeutics.

Alexandre Ambrogelly1, Stephen Gozo2, Amit Katiyar3, Shara Dellatore4, Yune Kune5, Ram Bhat6, Joanne Sun7, Ning Li8, Dongdong Wang9, Christine Nowak10, Alyssa Neill10, Gomathinayagam Ponniah10, Cory King10, Bruce Mason11, Alain Beck12, Hongcheng Liu10.   

Abstract

Process changes are inevitable in the life cycle of recombinant monoclonal antibody therapeutics. Products made using pre- and post-change processes are required to be comparable as demonstrated by comparability studies to qualify for continuous development and commercial supply. Establishment of comparability is a systematic process of gathering and evaluating data based on scientific understanding and clinical experience of the relationship between product quality attributes and their impact on safety and efficacy. This review summarizes the current understanding of various modifications of recombinant monoclonal antibodies. It further outlines the critical steps in designing and executing successful comparability studies to support process changes at different stages of a product's lifecycle.

Keywords:  comparability; post-translational modifications; recombinant monoclonal antibodies

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Year:  2018        PMID： 29513619      PMCID： PMC5973765          DOI： 10.1080/19420862.2018.1438797

Source DB:  PubMed          Journal:  MAbs        ISSN： 1942-0862            Impact factor:   5.857


  244 in total

1.  High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans.

Authors:  Andrew M Goetze; Y Diana Liu; Zhongqi Zhang; Bhavana Shah; Edward Lee; Pavel V Bondarenko; Gregory C Flynn
Journal:  Glycobiology       Date:  2011-03-18       Impact factor: 4.313

2.  Post-translational modifications differentially affect IgG1 conformation and receptor binding.

Authors:  Damian Houde; Yucai Peng; Steven A Berkowitz; John R Engen
Journal:  Mol Cell Proteomics       Date:  2010-01-26       Impact factor: 5.911

3.  Monitoring of IgG antibody thermal stability by micellar electrokinetic capillary chromatography and matrix-assisted laser desorption/ionization mass spectrometry.

Authors:  A J Alexander; D E Hughes
Journal:  Anal Chem       Date:  1995-10-15       Impact factor: 6.986

4.  Classification and characterization of therapeutic antibody aggregates.

Authors:  Marisa K Joubert; Quanzhou Luo; Yasser Nashed-Samuel; Jette Wypych; Linda O Narhi
Journal:  J Biol Chem       Date:  2011-03-25       Impact factor: 5.157

5.  Intrachain disulfide bond in the core hinge region of human IgG4.

Authors:  J W Bloom; M S Madanat; D Marriott; T Wong; S Y Chan
Journal:  Protein Sci       Date:  1997-02       Impact factor: 6.725

6.  Analysis of nonhuman N-glycans as the minor constituents in recombinant monoclonal antibody pharmaceuticals.

Authors:  Eiki Maeda; Soichiro Kita; Mitsuhiro Kinoshita; Koji Urakami; Takao Hayakawa; Kazuaki Kakehi
Journal:  Anal Chem       Date:  2012-02-24       Impact factor: 6.986

7.  Studies of aglycosylated chimeric mouse-human IgG. Role of carbohydrate in the structure and effector functions mediated by the human IgG constant region.

Authors:  M H Tao; S L Morrison
Journal:  J Immunol       Date:  1989-10-15       Impact factor: 5.422

8.  Defucosylated chimeric anti-CC chemokine receptor 4 IgG1 with enhanced antibody-dependent cellular cytotoxicity shows potent therapeutic activity to T-cell leukemia and lymphoma.

Authors:  Rinpei Niwa; Emi Shoji-Hosaka; Mikiko Sakurada; Toyohide Shinkawa; Kazuhisa Uchida; Kazuyasu Nakamura; Kouji Matsushima; Ryuzo Ueda; Nobuo Hanai; Kenya Shitara
Journal:  Cancer Res       Date:  2004-03-15       Impact factor: 12.701

9.  Marketing approval of mogamulizumab: a triumph for glyco-engineering.

Authors:  Alain Beck; Janice M Reichert
Journal:  MAbs       Date:  2012-07-01       Impact factor: 5.857

10.  Human IgG is produced in a pro-form that requires clipping of C-terminal lysines for maximal complement activation.

Authors:  Ewald T J van den Bremer; Frank J Beurskens; Marleen Voorhorst; Patrick J Engelberts; Rob N de Jong; Burt G van der Boom; Erika M Cook; Margaret A Lindorfer; Ronald P Taylor; Patrick Hc van Berkel; Paul Whi Parren
Journal:  MAbs       Date:  2015       Impact factor: 5.857
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  13 in total

1.  Risk-Based Comparability Assessment for Monoclonal Antibodies During Drug Development: A Clinical Pharmacology Perspective.

Authors:  Yanli Zhuang; Di Chen; Amarnath Sharma; Zhenhua Xu
Journal:  AAPS J       Date:  2018-10-15       Impact factor: 4.009

Review 2.  Mass spectrometry for the identification and analysis of highly complex glycosylation of therapeutic or pathogenic proteins.

Authors:  Yukako Ohyama; Kazuki Nakajima; Matthew B Renfrow; Jan Novak; Kazuo Takahashi
Journal:  Expert Rev Proteomics       Date:  2020-05-28       Impact factor: 3.940

3.  Covalent labeling and mass spectrometry reveal subtle higher order structural changes for antibody therapeutics.

Authors:  Patanachai Limpikirati; John E Hale; Mark Hazelbaker; Yongbo Huang; Zhiguang Jia; Mahdieh Yazdani; Eric M Graban; Robert C Vaughan; Richard W Vachet
Journal:  MAbs       Date:  2019-02-06       Impact factor: 5.857

4.  Fast Afucosylation Profiling of Glycoengineered Antibody Subunits by Middle-Up Mass Spectrometry.

Authors:  Elsa Wagner-Rousset; Olivier Colas; Stéphane Chenu; Yannis-Nicolas François; Davy Guillarme; Sarah Cianferani; Yury O Tsybin; Jonathan Sjögren; Arnaud Delobel; Alain Beck
Journal:  Methods Mol Biol       Date:  2021

Review 5.  Micro-Heterogeneity of Antibody Molecules.

Authors:  Yusuke Mimura; Radka Saldova; Yuka Mimura-Kimura; Pauline M Rudd; Roy Jefferis
Journal:  Exp Suppl       Date:  2021

6.  High-throughput antibody screening from complex matrices using intact protein electrospray mass spectrometry.

Authors:  William S Sawyer; Neha Srikumar; Joseph Carver; Phillip Y Chu; Amy Shen; Ankai Xu; Ambrose J Williams; Christoph Spiess; Cong Wu; Yichin Liu; John C Tran
Journal:  Proc Natl Acad Sci U S A       Date:  2020-04-23       Impact factor: 11.205

7.  Native peptide mapping - A simple method to routinely monitor higher order structure changes and relation to functional activity.

Authors:  Michel Degueldre; Annemie Wielant; Eglantine Girot; Will Burkitt; John O'Hara; Gaël Debauve; Annick Gervais; Carl Jone
Journal:  MAbs       Date:  2019-10-04       Impact factor: 5.857

8.  Interlaboratory Study for Characterizing Monoclonal Antibodies by Top-Down and Middle-Down Mass Spectrometry.

Authors:  Kristina Srzentić; Luca Fornelli; Yury O Tsybin; Joseph A Loo; Henrique Seckler; Jeffrey N Agar; Lissa C Anderson; Dina L Bai; Alain Beck; Jennifer S Brodbelt; Yuri E M van der Burgt; Julia Chamot-Rooke; Sneha Chatterjee; Yunqiu Chen; David J Clarke; Paul O Danis; Jolene K Diedrich; Robert A D'Ippolito; Mathieu Dupré; Natalia Gasilova; Ying Ge; Young Ah Goo; David R Goodlett; Sylvester Greer; Kim F Haselmann; Lidong He; Christopher L Hendrickson; Joshua D Hinkle; Matthew V Holt; Sam Hughes; Donald F Hunt; Neil L Kelleher; Anton N Kozhinov; Ziqing Lin; Christian Malosse; Alan G Marshall; Laure Menin; Robert J Millikin; Konstantin O Nagornov; Simone Nicolardi; Ljiljana Paša-Tolić; Stuart Pengelley; Neil R Quebbemann; Anja Resemann; Wendy Sandoval; Richa Sarin; Nicholas D Schmitt; Jeffrey Shabanowitz; Jared B Shaw; Michael R Shortreed; Lloyd M Smith; Frank Sobott; Detlev Suckau; Timothy Toby; Chad R Weisbrod; Norelle C Wildburger; John R Yates; Sung Hwan Yoon; Nicolas L Young; Mowei Zhou
Journal:  J Am Soc Mass Spectrom       Date:  2020-08-19       Impact factor: 3.109

9.  Development and validation of a platform reduced intact mass method for process monitoring of monoclonal antibody glycosylation during routine manufacturing.

Authors:  Michael Schilling; Pamela Feng; Zoran Sosic; Stacey L Traviglia
Journal:  Bioengineered       Date:  2020-12       Impact factor: 3.269

Review 10.  Principles of N-Linked Glycosylation Variations of IgG-Based Therapeutics: Pharmacokinetic and Functional Considerations.

Authors:  Souad Boune; Peisheng Hu; Alan L Epstein; Leslie A Khawli
Journal:  Antibodies (Basel)       Date:  2020-06-10
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