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Analytical comparability study of recombinant monoclonal antibody therapeutics |
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| Authors: | Alexandre Ambrogelly Stephen Gozo Amit Katiyar Shara Dellatore Yune Kune Ram Bhat |
| Affiliation: | 1. Biologics Analytical Operations, Pharmaceutical &2. Biologics Development, Gilead Sciences, Ocean Ranch Blvd, Oceanside, CA;3. Analytical Research &4. Development-Biologics, Celgene Corporation, Morris Avenue, Summit, NJ;5. Analytical Development, Bristol-Myers Squibb, Pennington Rocky Road, Pennington, NJ;6. Biologics &7. Vaccines Bioanalytics, MRL, Merck &8. Co., Inc., Galloping Hill Road, Kenilworth, NJ USA;9. Fortress Biologicals, Sawyer Road, Suite, Waltham, MA;10. Millennium Research laboratories, New Boston Street, Woburn, MA |
| 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 recombinant monoclonal antibodies post-translational modifications |