Analytical comparability study of recombinant monoclonal antibody therapeutics

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


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.

Publication types

  • Comparative Study
  • Review

MeSH terms

  • Antibodies, Monoclonal / chemistry*
  • Chemistry, Pharmaceutical / methods*
  • Chemistry, Pharmaceutical / standards*
  • Drug Discovery
  • Humans
  • Protein Processing, Post-Translational
  • Quality Assurance, Health Care / methods*
  • Recombinant Proteins / chemistry*


  • Antibodies, Monoclonal
  • Recombinant Proteins