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Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System
Published on: May 1, 2019
Analytical comparability study of recombinant monoclonal antibody therapeutics
Alexandre Ambrogelly1, Stephen Gozo2, Amit Katiyar3
1a Biologics Analytical Operations, Pharmaceutical & Biologics Development, Gilead Sciences , Ocean Ranch Blvd, Oceanside , CA.
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.
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