Biosimilars and Bioanalytical Methods

Validation of a high throughput fluorescent Capillary Electrophoresis Sodium Dodecyl Sulfate method for monoclonal antibody size heterogeneity assessment

This study validates a fluorescence-based CE-SDS method for assessing monoclonal antibody size heterogeneity, showing high specificity and precision compared to UV-based methods.

The Immunogenicity Database Collaborative (IDC): A Standardized, Publicly Available Database for Clinical Immunogenicity Observations and Insights

The paper introduces the Immunogenicity Database (IDC) to standardize and integrate clinical immunogenicity data, highlighting trends in anti-drug antibody incidence and risk factors.

Statistical Methodology for Qualification of a Non-Clinical Risk Assessment Peptide:T Cell Proliferation Assay to Support Decision Making

The paper develops a statistical framework to validate a T cell proliferation assay for immunogenicity risk assessment in biologics development.

Enhanced protein precipitation with ammonia enables rapid, universal extraction of oligonucleotides for bioanalysis

This paper introduces a method to efficiently extract oligonucleotides from biological samples using ammonia-based protein precipitation, achieving near-complete recovery without costly steps.

Rapid and wash-free anti-drug antibody assay enabled by the complementary nanoluciferase biosensor

This paper introduces a wash-free homogeneous immunoassay using a split nanoluciferase biosensor for rapid anti-drug antibody detection across various therapeutic modalities.