Open AccessDevelopment and Validation of an Efficient and Highly Sensitive Enzyme-Linked Immunosorbent Assay for Alemtuzumab Quantification in Human Serum and Plasma
Author(s) -
Federica Achini-Gutzwiller,
Cornelia M. Jol–van der Zijde,
Anja M. Jansen-Hoogendijk,
Arjan C. Lankester,
Robbert G.M. Bredius,
Maarten J.D. van Tol,
Dirk Jan A. R. Moes,
Marco W. Schilham
Publication year - 2022
Publication title -
therapeutic drug monitoring
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 93
eISSN - 1536-3694
pISSN - 0163-4356
DOI - 10.1097/ftd.0000000000001037
Subject(s) - alemtuzumab , immunoassay , context (archaeology) , cd52 , coefficient of variation , monoclonal antibody , assay sensitivity , bioanalysis , detection limit , immunology , transplantation , medicine , antibody , pharmacology , chemistry , chromatography , biology , pathology , paleontology , alternative medicine
Alemtuzumab is a humanized monoclonal antibody that targets the CD52 glycoprotein expressed on most lymphocytes, subsequently inducing complement-mediated and antibody-mediated cytotoxicity. Owing to its ability to induce profound immune depletion, alemtuzumab is frequently used in patients before allogeneic hematopoietic stem cell transplantation to prevent graft rejection and acute graft-versus-host disease. In this clinical context, a stable immunoassay with high sensitivity and specificity to determine alemtuzumab levels is essential for performing pharmacokinetic and pharmacodynamic analyses; however, the available methods have several limitations. Here, we report the successful development and validation of an efficient and highly sensitive enzyme-linked immunosorbent assay technique based on commercially available reagents to quantify alemtuzumab in human serum or plasma.