Analytical Comparability Study of Recombinant Monoclonal Antibody Therapeutics

Overview

Journal MAbs

Specialty Allergy & Immunology

Date 2018 Mar 8

PMID 29513619

Citations 27

Authors

Alexandre Ambrogelly

Stephen Gozo

Amit Katiyar

Shara Dellatore

Yune Kune

Ram Bhat

Joanne Sun

Ning Li

Dongdong Wang

Christine Nowak

Alyssa Neill

Gomathinayagam Ponniah

Cory King

Bruce Mason

Alain Beck

Hongcheng Liu

Affiliations

Soon will be listed here.

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.

Citing Articles

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