Services

• Analytical services for product and process characterization: LC-MS based assays including Multi-Attribute Method (MAM) and intact/partial therapeutic protein analysis; CEX; SEC; CE-SDS; UVCD; DSC; binding assay etc. We also provide the analytical data package for characterization sections in IND and BLA filings.
• Consulting services for analytical development: MAM development and regulatory strategy; analytical development, qualification, validation, transfer; specification; stability; reference standard etc.
• Challenging analytical assays, e.g. HCP LC-MS analysis, sequence variant analysis, epitope mapping.