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Review
. 2018 May/Jun;10(4):513-538.
doi: 10.1080/19420862.2018.1438797. Epub 2018 Mar 20.

Analytical comparability study of recombinant monoclonal antibody therapeutics

Alexandre Ambrogelly  1 , Stephen Gozo  2 , Amit Katiyar  3 , Shara Dellatore  4 , Yune Kune  5 , Ram Bhat  6 , Joanne Sun  7 , Ning Li  8 , Dongdong Wang  9 , Christine Nowak  10 , Alyssa Neill  10 , Gomathinayagam Ponniah  10 , Cory King  10 , Bruce Mason  11 , Alain Beck  12 , Hongcheng Liu  10
Affiliations
Review

Analytical comparability study of recombinant monoclonal antibody therapeutics

Alexandre Ambrogelly et al. MAbs. 2018 May/Jun.

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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References

    1. Beck A, Wagner-Rousset E, Ayoub D, Van DA, Sanglier-Cianferani S. Characterization of therapeutic antibodies and related products. Anal Chem. 2013;85(2):715–36. doi: 10.1021/ac3032355. - DOI - PubMed
    1. Kozlowski S, Swann P. Current and future issues in the manufacturing and development of monoclonal antibodies. Adv Drug Deliv Rev. 2006;58 (5–6):707–22. doi: 10.1016/j.addr.2006.05.002. - DOI - PubMed
    1. Liu H, Ponniah G, Zhang HM, Nowak C, Neill A, Gonzalez-Lopez N, Patel R, Cheng G, Kita AZ, Andrien B. In vitro and in vivo modifications of recombinant and human IgG antibodies. MAbs. 2014;6 (5):1145–54. doi: 10.4161/mabs.29883. - DOI - PMC - PubMed
    1. Vlasak J, Ionescu R. Heterogeneity of monoclonal antibodies revealed by charge-sensitive methods. Curr Pharm Biotechnol. 2008;9(6):468–81. doi: 10.2174/138920108786786402 - DOI - PubMed
    1. FDA Guidance concerning demonstration of comparability of human biological products, including therapeutic biotechnology-derived products. FDA 1996. https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidan...

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