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Activity Number: 77 - Contributed Poster Presentations: Biopharmaceutical Section
Type: Contributed
Date/Time: Monday, August 3, 2020 : 10:00 AM to 2:00 PM
Sponsor: Biopharmaceutical Section
Abstract #313849
Title: Development of MSD Multiplex Antigenicity Assay
Author(s): Yongwei Liu* and Lingyi Zheng and Jason Szeto and Melinda Donovan and Tricia Chen
Companies: Sanofi Pasteur and Sanofi and Immunology Platform, Sanofi Pasteur and Immunology Platform, Sanofi Pasteur and Immunology Platform, Sanofi Pasteur
Keywords: MSD; multiplexing; assay development; parallelism; non-clinical; statistics
Abstract:

MesoScale Discovery (MSD) system is a multiplexing technology that allows simultaneous detection of multiple analytes within a single well of a 96-well plate. While multiplexing is efficient, such assays can be challenging to develop. A single multiplexed reference standard was used in order to simplify the plate layout, while maximizing the benefits of multiplexing. However, the reference standard curves for each antigen do not always present similar shapes compared to the test sample curves. Additionally, a single dilution is typically used for a multiplexed sample, which may result in some antigens being in a non-optimal concentration range. During the assay development, multiple data transformation methods, statistical models (i.e., linear vs. non-linear, weighted vs. unweighted) and parallelism assessment (i.e., significance test vs. equivalency test vs. CV%) were compared to ensure accuracy, precision, linearity, limits of quantitation (LLOQ/ULOQ) and compliance to regulatory requirements. Extensive experiments were conducted to ensure the MSD assay achieves optimal performance. Study funded by Sanofi Pasteur


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