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

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7 Citations (Scopus)

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

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Enzyme-Linked Immunosorbent Assay
B-Cell Chronic Lymphocytic Leukemia
Serum
Immunoglobulin G
Papain
Lymphoproliferative Disorders
Digestion
B-Lymphocytes
Therapeutics
Monoclonal Antibodies
alemtuzumab
Rabbits
Antibodies

Keywords

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

ASJC Scopus subject areas

  • Pharmacology

Cite this

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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.",
keywords = "Alemtuzumab, Autoimmune diseases, CD52 antigen, CLL, ELISA",
author = "M. Montagna and Avanzini, {M. A.} and L. Visai and F. Locatelli and M. Montillo and E. Morra and Regazzi, {Mario B.}",
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AU - Montagna, M.

AU - Avanzini, M. A.

AU - Visai, L.

AU - Locatelli, F.

AU - Montillo, M.

AU - Morra, E.

AU - Regazzi, Mario B.

PY - 2007/4

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AB - 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.

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KW - Autoimmune diseases

KW - CD52 antigen

KW - CLL

KW - ELISA

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