title: A new sensitive enzyme-linked immunosorbent assay (ELISA) for Alemtuzumab determination: development, validation and application.
abstract: Alemtuzumab is a humanized (IgG(1)) 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 IgG(1) 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.
authors.affiliation: Clinical Pharmacokinetics Unit, IRCCS-Fondazione Policlinico S. Matteo, Pavia, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Montagna
authors.forename: M A
authors.initials: MA
authors.lastname: Avanzini
authors.forename: L
authors.initials: L
authors.lastname: Visai
authors.forename: F
authors.initials: F
authors.lastname: Locatelli
authors.forename: M
authors.initials: M
authors.lastname: Montillo
authors.forename: E
authors.initials: E
authors.lastname: Morra
authors.forename: M B
authors.initials: MB
authors.lastname: Regazzi
mesh_terms: D000074323:Alemtuzumab; D000818:Animals; D000911:Antibodies, Monoclonal / Q000032:analysis* / Q000097:blood; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000032:analysis* / Q000097:blood; D000970:Antineoplastic Agents / Q000032:analysis* / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000097:blood; D011817:Rabbits; D051381:Rats
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D000970:Antineoplastic Agents; D000074323:Alemtuzumab