Authors
Yongjun Xue, Eric Ma, Brian Melo, Madhan Masilamani, Yiming Cheng, Jim X Shen, M Shane Woolf, Korrey D Allen, Jordan M Honrine, Michael P Waldron, William R Mylott
Published in
Bioanalysis. Pages 1-13. Aug 17, 2026. Epub Aug 17, 2026.
Abstract
Quantitating antibody drug conjugates (ADCs) with traditional ligand binding assays (LBAs) requires cytotoxic payload targeting reagents, which may be needed for ADC capture/detection. LBAs are drug antibody ratio insensitive (DAR insensitive) and prone to under- or over-estimating DAR species.
This hybrid LBA LC MS/MS assay measures concentrations for a novel ADC drug (BMS-X) with an engineered, site‑specific, non-cleavable linker, and a unique payload. Recombinant target protein-extracellular domain fused with mouse IgG-Fc was used for ADC pull down in human serum. Pepsin digestion released unique toxin linker peptide complexes for two conjugation sites.
This novel, validated DAR-sensitive hybrid-LCMS PK assay measured payload-conjugated BMS-X levels in human serum, quantitated surrogate analytes for both unique conjugation sites, and was used to support a first-in-human clinical trial.
PMID:
42605537
Bibliographic data and abstract were imported from PubMed on 17 Aug 2026.
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