Evaluating Environmental Temperature as a Hidden Critical Factor in icIEF for a Late-Stage ADC

• Explaining how method validation failures revealed environmental temperature as an overlooked driver of icIEF performance during method development
• Small increases in ambient temperature disrupt separation, impacting ADC charge variant profiling and data reliability
• Defining a controlled temperature window to enable robust, transferable icIEF performance across sites and instruments for a late-stage ADC

Speakers:

Ha Le

Senior Scientist, Biologics Analytical R&D

Merck & Co