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

ABSTRACT

Background: 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. Methodology & results: 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. Conclusion: These results suggest that PCA ELISA can be used as a valuable method for quality testing of antibodies.