Multi-Attribute Assay Sample Preparation in the µSI Process Analyzer System
The multi-attribute method (MAM) assay utilizes peptide mapping methodology to identify and quantify critical quality attributes (CQAs). It is typically performed off-line through manual sample handling, followed by Liquid Chromatography-Mass Spectroscopy (LC-MS) operation, and generating results can take several days. Transitioning the off-line, manual MAM assay into a real-time online LC-MS integrated µSI process analyzer system, where results can be obtained within 2 to 3 hours, can guide process development activities, and provide valuable insights into the performance of a biomanufacturing process.