Process analytics for purification of monoclonal antibodies

J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Mar 15;848(1):79-87. doi: 10.1016/j.jchromb.2006.11.018. Epub 2006 Dec 11.

Abstract

The application of appropriate analytical methods is an essential requirement for the purification of therapeutic antibodies. A range of analytical methods need to be employed to effectively determine the purity, identity, integrity and activity of these important class of pharmaceuticals. These include notably electrophoresis, high performance liquid chromatography and immunoassays. Regulatory and industry demands in recent years have brought the need for improvements and many have been successfully implemented. This article reviews the current analytical methods applied to support the purification of monoclonal antibodies.

Publication types

  • Review

MeSH terms

  • Animals
  • Antibodies, Monoclonal / chemistry
  • Antibodies, Monoclonal / isolation & purification*
  • Chromatography, High Pressure Liquid / methods
  • Electrophoresis / methods
  • Enzyme-Linked Immunosorbent Assay / methods
  • Humans

Substances

  • Antibodies, Monoclonal