Project Overview

Development and implementation of hybrid LBA-LC-MS/MS assays for quantitation of biotherapeutics in plasma.

The Challenges

• Training a diverse team of scientists in protein quantification
• Developing a selective and highly sensitive MS/MS assay for a biotherapeutic target in plasma
• Choosing the best signature peptides for quantitation
• Optimization of sample enrichment and chromatographic conditions

The Solution

SCIEX Biologics Quant Platform

• Immunoaffinity enrichment sample prep kit with lab tested protocols
• High sensitivity LC- MS/MS hardware
• Powerful software for peptide MRM optimization
• Scientific training and technical support from SCIEX experts

The Outcomes

• Workflow training from SCIEX for entire team to accelerate method development
• Method developed for trastuzumab quantitation using three different signature peptides
• Utilized immunoaffinity enrichment as a hybrid LBA-LC/MS/MS approach
• Demonstrated acceptable calibration and QC for immunocaptured samples
• Completed partial validation of trastuzumab biologic in rat plasma
• Continued work on full validation of trastuzumab in human plasma using the hybrid LBA-LC/MS/MS approach