High-Throughput Monitoring of Biotherapeutic Critical Quality Attributes with High-Resolution Ion Mobility-Mass Spectrometry (HRIM-MS)
Post-translational modifications (PTMs) to peptides can disrupt secondary and tertiary protein structure leading to changes in safety or efficacy of protein-based therapeutics. Monitoring of PTMs to ensure production and distribution of safe and efficacious biotherapeutics requires robust and high-throughput analytical techniques capable of detecting extremely small differences in structure. Traditional Liquid Chromatography-Mass Spectrometry (LC-MS) peptide mapping workflows are time consuming and complex, resulting in delayed project turnaround timelines (TATs). We implemented HRIM technology into traditional LC-MS peptide mapping characterization workflows to perform rapid, targeted analysis of Critical Quality Attributes (CQAs) that are often difficult to separate or potentially go undetected with platform LC-MS methods.
- MOBIE provides reproducible high-resolution separation of a target native Asp and modified isoAsp peptide pair across multiple LC gradients ranging from 20-min to 5-min
- The MOBIE platform allows for separation of select targeted isobaric and isomeric PTMs such as deamidation and isomerization, enabling rapid characterization of target PTMs in a 20-minLC-HRIM-MS workflow
- Integration with Protein Metrics Data Processing Workflows (Byos for HRIM) facilitates streamlined and efficient data processing of biopharmaceutical characterization data sets