Flow cytometry in the preclinical development of biopharmaceuticals.


Conference Paper

Novel biomarkers are often required in the preclinical development of biopharmaceuticals in order to characterize pharmacologic and toxicologic effects and to establish pharmacodynamic and pharmacokinetic relationships. Flow cytometry is uniquely suited for measurement of these biomarkers. Large numbers of single cells in a heterogeneous population can be rapidly identified and characterized with high accuracy and reproducibility. Cells are not damaged by the detection system and can be subsequently sorted for further morphologic or functional analysis. The availability of clinical instruments and a wide range of fluorescent probes have made this technology applicable for use in toxicologic clinical pathology. Flow cytometry has played an integral role in the development of a monoclonal antibody to human CD4 (keliximab, IDEC-CE9.1, SB 210396). Lymphocyte subset analysis and assays for expression, coating, and modulation of human CD4 were used for sequential assessment of the pharmacologic activity of keliximab in transgenic mice expressing human CD4.

Full Text

Cited Authors

  • Gossett, KA; Narayanan, PK; Williams, DM; Gore, ER; Herzyk, DJ; Hart, TK; Sellers, TS

Published Date

  • January 1999

Published In

Volume / Issue

  • 27 / 1

Start / End Page

  • 32 - 37

PubMed ID

  • 10367670

Pubmed Central ID

  • 10367670

Electronic International Standard Serial Number (EISSN)

  • 1533-1601

International Standard Serial Number (ISSN)

  • 0192-6233

Digital Object Identifier (DOI)

  • 10.1177/019262339902700107