A new sensitive enzyme-linked immunosorbent assay (Elisa) for alemtuzumab determination: Development, validation and application

M. Montagna, M. A. Avanzini, L. Visai, F. Locatelli, M. Montillo, E. Morra, Mario B. Regazzi

Research output: Contribution to journalArticle

Abstract

Alemtuzumab is a humanized (IgG1) rat monoclonal antibody to CD52 antigen and is currently used in the treatment of chronic lymphocytic leukemia (CLL) and other CD52-positive lymphoproliferative disorders. Various techniques have been developed to measure Alemtuzumab levels in human serum/ plasma. The authors report on the validation of a very sensitive enzyme-linked immunosorbent assay (ELISA) to measure serum concentrations of the humanized IgG1 using a rabbit polyclonal antibody specifically produced against the rat sequence of Alemtuzumab after papain digestion. The assay was successfully applied to test the serum samples of patients with B-lymphocyte CLL who received Alemtuzumab subcutaneously. This ELISA assay could be easily used to determine human serum levels of Alemtuzumab pre- and post-treatment to optimize dosing and scheduling and to study the relationship between dose and clinical response.

Original languageEnglish
Pages (from-to)363-371
Number of pages9
JournalInternational Journal of Immunopathology and Pharmacology
Volume20
Issue number2
Publication statusPublished - Apr 2007

Keywords

  • Alemtuzumab
  • Autoimmune diseases
  • CD52 antigen
  • CLL
  • ELISA

ASJC Scopus subject areas

  • Pharmacology

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