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

Gong J, Wang X & Hackmann J | Bioanalysis, 14(23), 1479-1486, (2022)

Keywords: • critical reagent management • ELISA • higher order structure (HOS) • monoclonal antibodies • protein conformational array (PCA) technology

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.

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