S. Letarte

Qualification of Identity, Quality-Attribute Monitoring and New Peak Detection in An Improved Multi-Attribute Method with Lys-C Digestion for Characterization and Quality Control of Therapeutic Monoclonal Antibodies

This paper qualifies an improved multi-attribute method (MAM) for mAb identity, quality attributes, and new peak detection using Lys-C digestion and high-resolution MS.

Improvements on Sample Preparation and Peptide Separation for Reduced Peptide Mapping Based Multi-Attribute Method analysis of Therapeutic Monoclonal Antibodies Using Lys-C Digestion

This paper improves sample preparation and peptide separation for reduced peptide mapping-based MAM analysis of therapeutic monoclonal antibodies using Lys-C digestion, enhancing PQA monitoring for hydrophilic peptides.

Profiling Active Enzymes for Polysorbate Degradation in Biotherapeutics by Activity-Based Protein Profiling

This study uses activity-based protein profiling to identify active enzymes causing polysorbate degradation in biotherapeutic production, finding more enzymes than traditional proteomics methods.

Identification and Characterization of a Residual Host Cell Protein Hexosaminidase B Associated with N-glycan Degradation During the Stability Study of a Therapeutic Recombinant Monoclonal Antibody Product

The paper identifies Hexosaminidase B as a residual host cell protein causing N-glycan degradation in a monoclonal antibody under stability conditions and develops strategies to mitigate its impact.