Vice President, Scientific Strategy Prolytix Essex Junction, Vermont, United States
Description: Contamination of biotherapeutics with HCPs can pose a significant risk to safety and efficacy of the drug product. Commercial ELISA kits are available to determine the amount of HCPs in your drug product or in-process samples. While these commercial kits may be appropriate for the intended use, what objective evidence should be provided to verify the performance characteristics of these kits? How can HRMS inform this decision?
Learning Objectives:
Understand the risks associated with the use of a commercial ELISA kit to determine the level of HCPs in your biotherapeutic.
Understand how HRMS can help confirm the commercial ELISA kit is appropriate for the intended use.
Understand how evaluation of HCPs by HRMS can better inform decisions.
