Metrics for antibody therapeutics development

MAbs. 2010 Nov-Dec;2(6):695-700. doi: 10.4161/mabs.2.6.13603. Epub 2010 Nov 1.

Abstract

A wide variety of full-size monoclonal antibodies (mAbs) and therapeutics derived from alternative antibody formats can be produced through genetic and biological engineering techniques. These molecules are now filling the preclinical and clinical pipelines of every major pharmaceutical company and many biotechnology firms. Metrics for the development of antibody therapeutics, including averages for the number of candidates entering clinical study and development phase lengths for mAbs approved in the United States, were derived from analysis of a dataset of over 600 therapeutic mAbs that entered clinical study sponsored, at least in part, by commercial firms. The results presented provide an overview of the field and context for the evaluation of on-going and prospective mAb development programs. The expansion of therapeutic antibody use through supplemental marketing approvals and the increase in the study of therapeutics derived from alternative antibody formats are discussed.

Publication types

  • Editorial
  • Review

MeSH terms

  • Antibodies, Monoclonal / therapeutic use*
  • Clinical Trials as Topic
  • Drug Discovery / statistics & numerical data*
  • Drug Discovery / trends*
  • Humans

Substances

  • Antibodies, Monoclonal