Validation of a microfluidic platform to measure total therapeutic antibodies and incurred sample reanalysis performance.

Background: A microfluidic platform-based assay was validated to measure a humanized or fully human IgG in rat serum samples.

Materials & Methods: The cumulative assessment for accuracy and precision was performed with three accuracy and precision runs.

Results: The inter-assay accuracy (mean %bias) ranged from -4.

Impact of anti-drug antibodies in preclinical pharmacokinetic assessment.

The administration of human biotherapeutics is often associated with a higher incidence of immunogenicity in preclinical species. The presence of anti-drug antibodies (ADAs) in the test samples can affect the accurate measurement of therapeutic protein (TP) in bioanalytical methods designed to support pharmacokinetic (PK) and toxicokinetic (TK) assessments. The impact can vary depending on the bioanalytical method platform and study dosing design.

Model-based strategy for bioanalytical method comparison: measurement of a soluble ligand as a biomarker.

Ligand binding assays (LBAs) are often the method of choice for quantification of protein biomarkers and therapeutic biologics during drug development. Soluble ligand X is a glycoprotein. To understand the role of circulating ligand X in drug-target relationship, an analytical method (Method 1) was developed and validated to measure circulating ligand X and to support early clinical studies.