Assay pH and critical reagent optimization in measuring concentrations of a monoclonal antibody and its target

Author:

Chen Jihua1,Kendra Kimberly1,Shank Stacey1,Rafique Ashique1,Ehrlich George1,Lin Kuan-Ju1,DeStefano Lisa1,Andisik Matthew D1,Partridge Michael A1,Torri Albert1,Sumner Giane1

Affiliation:

1. Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA

Abstract

Aim: To mitigate assay interference in the drug and target assays to support the development of monoclonal antibody REGN-Z. Results: Mild acidic assay conditions and capture and detection antibodies with different affinities and t1/2 under different assay pHs were used to mitigate interference in the total drug and total target assays. A free target assay was also developed using a lower-affinity capture antibody with a much slower association and dissociation rate. The impact of sample incubation, dilution and storage on the accurate detection of the free target was also evaluated. Conclusion: The total drug, total and free target assays can accurately quantitate drug and target concentrations when tested with a subset of clinical study samples.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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