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

Affiliations

¹ a Biologics Analytical Operations, Pharmaceutical & Biologics Development, Gilead Sciences , Ocean Ranch Blvd, Oceanside , CA.
² b Analytical Research & Development-Biologics, Celgene Corporation , Morris Avenue, Summit , NJ.
³ c Analytical Development, Bristol-Myers Squibb , Pennington Rocky Road, Pennington , NJ.
⁴ d Biologics & Vaccines Bioanalytics, MRL, Merck & Co., Inc. , Galloping Hill Road, Kenilworth , NJ USA.
⁵ e Fortress Biologicals , Sawyer Road, Suite, Waltham , MA.
⁶ f Millennium Research laboratories , New Boston Street, Woburn , MA.
⁷ g Product Development, Innovent Biologics , Dongping Street, Suzhou Industrial Park , China.
⁸ h Analytical Chemistry, Regeneron Pharmaceuticals, Inc. , Old Saw Mill River Road, Tarrytown , NY.
⁹ i Analytical Department , BioAnalytix, Inc. , Memorial Drive, Cambridge , MA.
¹⁰ j Product Characterization, Alexion Pharmaceuticals , College Street, New Haven , CT.
¹¹ k Pre-formulation, Alexion Pharmaceuticals , College Street, New Haven , CT.
¹² l Analytical Chemistry, NBEs, Center d'Immunologie Pierre Fabre , St Julien-en-Genevois Cedex , France.

PMID: 29513619
PMCID: PMC5973765
DOI: 10.1080/19420862.2018.1438797

Review

Analytical comparability study of recombinant monoclonal antibody therapeutics

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

. 2018 May/Jun;10(4):513-538.

doi: 10.1080/19420862.2018.1438797. Epub 2018 Mar 20.

Authors

Affiliations

¹ a Biologics Analytical Operations, Pharmaceutical & Biologics Development, Gilead Sciences , Ocean Ranch Blvd, Oceanside , CA.
² b Analytical Research & Development-Biologics, Celgene Corporation , Morris Avenue, Summit , NJ.
³ c Analytical Development, Bristol-Myers Squibb , Pennington Rocky Road, Pennington , NJ.
⁴ d Biologics & Vaccines Bioanalytics, MRL, Merck & Co., Inc. , Galloping Hill Road, Kenilworth , NJ USA.
⁵ e Fortress Biologicals , Sawyer Road, Suite, Waltham , MA.
⁶ f Millennium Research laboratories , New Boston Street, Woburn , MA.
⁷ g Product Development, Innovent Biologics , Dongping Street, Suzhou Industrial Park , China.
⁸ h Analytical Chemistry, Regeneron Pharmaceuticals, Inc. , Old Saw Mill River Road, Tarrytown , NY.
⁹ i Analytical Department , BioAnalytix, Inc. , Memorial Drive, Cambridge , MA.
¹⁰ j Product Characterization, Alexion Pharmaceuticals , College Street, New Haven , CT.
¹¹ k Pre-formulation, Alexion Pharmaceuticals , College Street, New Haven , CT.
¹² l Analytical Chemistry, NBEs, Center d'Immunologie Pierre Fabre , St Julien-en-Genevois Cedex , France.

PMID: 29513619
PMCID: PMC5973765
DOI: 10.1080/19420862.2018.1438797

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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Analytical comparability study of recombinant monoclonal antibody therapeutics

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Analytical comparability study of recombinant monoclonal antibody therapeutics

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