Caprion applies its expertise in proteomics and development of quantitative assays to support PK studies. Our MRM mass spectrometry-based assays provide robust, accurate and precise quantitation of a target protein (biotherapeutic) in biological matrices. We also apply our expertise in mass spectrometry to comprehensive analysis of both the large and small molecule components of Antibody-Drug Conjugates (ADCs). Caprion has a strong track record for developing custom assays requiring complex sample preparation and mass spectrometry analysis.
- Absolute quantitation of target protein, including those that may be difficult to perform with standard immunoassays
- Multiplexed assays for concomitant analysis of biotherapeutic and PD markers
- Characterization of ADCs, including total antibody, conjugated antibody, free drug and distribution of drug-to-antibody ratio (DAR)
Benefits of Caprion’s MRM-based PK Assays
Caprion provides custom assay development for biotherapeutics, as well as assay transfer or adaptation, assay validation and analysis of study samples.
- High selectivity, including differentiation of isoforms and of endogenous vs. biotherapeutic protein
- Simultaneous detection and quantitation of multiple peptides of biotherapeutic
- Option for antibody-free or antibody-assisted approach
- Assay validation and analysis of study samples in a GLP environment, in compliance with FDA and EMEA guidelines on bioanalytical method validation.