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Current Analytical Chemistry

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ISSN (Print): 1573-4110
ISSN (Online): 1875-6727

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Research Article

A Novel Electrochemiluminescence (ECL) Immunoassay for the Quantitation of Monoclonal Antibody (mAb) PYX-106 in Human Serum

Author(s): Feng Yin*, Diana Adhikari, Xiaodong F. Liu, Jianxin Wang, Wensheng Yang, Gabriela A. Balogh, Teri Simon, Wenji Lei, Mariana Squicciarini, Lisa Bruce, Yan Ke, Mike Dyszel, Shawn Harriman* and Jan Pinkas*

Volume 20, Issue 6, 2024

Published on: 27 March, 2024

Page: [438 - 448] Pages: 11

DOI: 10.2174/0115734110293837240320042928

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Abstract

Background: PYX-106 is a novel monoclonal antibody (mAb), targeting the sialic acidbinding immunoglobulin-like lectin 15 (Siglec-15) in the Tumor Microenvironment (TME). Precise measurement of PYX-106 is essential for the thorough assessment of PYX-106 pharmacokinetics in clinical investigations.

Methods: A novel Electrochemiluminescence (ECL) immunoassay for the quantitation of PYX- 106 in human serum was developed and validated. Biotinylated anti-PYX-106 antibody Bio-A1A1 was employed as the capture antibody, and ruthenylated anti-PYX-106 antibody Ru-A3G10 was utilized as the detection antibody in the ECL immunoassay on Meso Scale Discovery (MSD) platform.

Results: This assay was fully validated in terms of selectivity, accuracy, precision, hook effect, stability, etc., with a dynamic range from 50.0 to 2,500 ng/mL in human serum under the 2018 U.S. Food and Drug Administration (FDA) guidance and the 2022 U.S. FDA ICH M10 guidance.

Conclusion: PYX-106 bioanalytical assay validation was reported for the first time in a biological matrix, and this assay has been successfully applied to support a clinical trial PYX-106-101.

Keywords: mAb, PYX-106, siglec-15, oncology, ECL, MSD.

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