Leary, Beth A., Lawrence-Henderson, Rosemary, Mallozzi, Carolyn, Fernandez Ocana, Mireia, Duriga, Nicole, O'Hara, Denise, Kavosi, Mania, Qiang, Qu and Joyce, Alison (2013) Bioanalytical platform comparison using a generic human IgG PK assay format. Journal of Immunological Methods, 397 (1-2). pp. 28-36. ISSN 0022-1759

Abstract

A comparison of four different ligand-binding assay technology platforms (ELISA, Meso Scale Discovery®, Gyros® and AlphaLISA®) was conducted using quantitative assays for the measurement of a human IgG1 monoclonal antibody (MAb) in rat serum. The assays used common reagents for Fc-specific measurement to determine total levels of a human IgG MAb drug analyte, and all were fully optimized for use on each platform. Mock MAb study samples were prepared and analyzed using all platforms to assess assay performance. Assay parameters such as sensitivity, dynamic range, minimum required dilution and sample volume as well as other considerations such as per-run cost, technology availability, requisite equipment and necessary reagent modifications were evaluated toward the determination of a default go-to assay platform for monoclonal antibody biotherapeutics in this laboratory. Based primarily on superior assay performance, Meso Scale Discovery and Gyros were selected from the four technologies evaluated as our default platforms for non-regulated (discovery) study support. As an adjunct, immunoaffinity LC-MS/MS was explored as an alternate platform for generic Fc quantitation and was found to perform similarly to the ligand-binding assays. © 2013 Elsevier B.V.

Item Type:	Article
Keywords:	Generic IgG assay Immunoaffinity Immunoassay Ligand-binding assay (LBA) Mass spectrometry
Date Deposited:	26 Jan 2018 00:45
Last Modified:	25 Jan 2019 00:46
URI:	https://oak.novartis.com/id/eprint/11134