A Comprehensive Immunocapture-LC-MS/MS Bioanalytical Approach in Support of a Biotherapeutic Ocular PK Study

• DOI: 10.3390/ph17020193
• Publication Date: 2024-01-31T14:56:34Z
• Authors: Lin-Zhi Chen; David Roos; Elsy Philip; Emily G. Werth; Stephanie Kostuk; Hongbin Yu; Holger Fuchs
• Keywords: Bioanalysis

BI-X, a therapeutic protein under development for the treatment of human ocular disease via intravitreal administration, binds to its targets and endogenous albumin in vitreous humor. A monkey pharmacokinetic (PK) study following BI-X administration was conducted measure drug levels plasma, humor, aqueous retina tissue at various timepoints post-dose. comprehensive bioanalytical approach implemented support this study. Five immunocapture-LC-MS/MS assays were developed qualified quantitating different matrices, while ELISA used measurement. Immunocapture or peptide level evaluated achieve adequate assay sensitivity. Drug applied analysis samples.