Two-Cycle Immunoaffinity Enrichment Strategy with Acid Treatment to Enhance Biotherapeutics Assay Sensitivity in Tissues.

ABSTRACT: Accurate and sensitive bioanalysis of therapeutic antibodies and proteins is crucial for ensuring reliable pharmacokinetic and toxicokinetic assessments. Immunoaffinity (IA) LC/MS/MS plays an important role in quantifying therapeutic antibodies in biological matrices due to its high specificity and less stringent reagent requirements compared to ligand binding assays. However, when analyzing complex tissue matrices, a single immunoaffinity enrichment cycle often leaves unwanted nonspecifically bound proteins in the final samples, resulting in high background noise levels and decreased assay sensitivity. To overcome this challenge, a novel two-cycle immunoaffinity LC-MS/MS method was evaluated for quantifying a mouse IgG2a antibody in mouse tumor, liver, and lung tissues. This method involv

SUBMITTER: Zhang Y 

PROVIDER: S-EPMC12291038 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature