Moving Beyond Average DAR Toward Advanced Strategies for Measuring & Controlling the Full Drug Load Distribution
- Compare the resolution and denaturing conditions of HIC versus reversed-phase LC-MS for DAR species separation to select the optimal stability method
- Implement native mass spectrometry for intact DAR analysis to provide a direct measurement without disrupting the native protein structure, gaining a true representation of drug distribution and identifying critical low-abundance species
- Develop orthogonal methods to overcome HIC’s poor resolution and HPLC RP’s denaturation, to understand DAR distribution, providing a robust package for regulatory filings, andensure consistent product quality