title: Development of an ELISA for the Pharmacokinetic Evaluation of a Murine Anti CD66 Monoclonal Antibody in Human Serum.
abstract: An enzyme-linked immunosorbent assay (ELISA) was needed to assist in the pharmacokinetic evaluation of the murine antibody conjugate CHX A" DTPA Besilesomab in serum samples in a clinical trial . A search failed to locate a validated assay that quantified murine antibodies in human serum so the purpose of this article was to develop a robust assay, validated against current guidelines. A detailed method for an ELISA to measure a murine antibody in human serum is described. The assay was validated as fit for purpose against the target values of coefficient of variation < 20% and accuracy ± 20%.
authors.affiliation: a Cancer Sciences Unit, Faculty of Medicine , Southampton University , United Kingdom.
authors.forename: J
authors.initials: J
authors.lastname: Langford
authors.forename: F
authors.initials: F
authors.lastname: Chowdhury
authors.forename: K
authors.initials: K
authors.lastname: Orchard
mesh_terms: D000818:Animals; D058846:Antibodies, Monoclonal, Murine-Derived / Q000493:pharmacokinetics* / Q000494:pharmacology; D015703:Antigens, CD / Q000097:blood*; D015815:Cell Adhesion Molecules / Q000037:antagonists & inhibitors* / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D051379:Mice; D010949:Plasma / Q000378:metabolism*; D019275:Radiopharmaceuticals / Q000493:pharmacokinetics* / Q000494:pharmacology
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D015703:Antigens, CD; C069847:CD66 antigens; D015815:Cell Adhesion Molecules; D019275:Radiopharmaceuticals; C578104:besilesomab
keywords: ELISA; human serum; immunoassay; murine antibody; pharmacokinetic; validation