A systematic and sensitive method for critical reagent antibody evaluation with PCA technology.

Quality control of critical reagents is essential in basic research and in drug discovery and development. Protein conformational array (PCA) is an ELISA-based technology that has been successfully used for the development of novel and biosimilar biologics with excellent sensitivity and accuracy. PCA ELISA is able to monitor higher order structure changes of mouse and rabbit antibodies under various stress and storage conditions. This study focused on the short- and long-term storage of antibodies and antiserum as well as the effect of multiple freeze-thaw cycles on the impact of antibody higher order structure. These results suggest that PCA ELISA can be used as a valuable method for quality testing of antibodies.