Evaluation of Residual Protein ELISA Stability of Precoated Plates and Assay Control in a Hight Throughput Environment

Abstract

Evaluation of Enzyme Linked Immunoassay Sorbent Assay (ELISA) overall stability on precoated plates to appraise Residual Protein levels in a wide variety of drug substance samples and filtration process reduces turn around time and give analyst more flexibility on their testing schedule. Results obtained on precoated plates at 5C and -20C showed a positive outcome when the optical densities and the actual titers were compared to the control group. Precoating plates for Residual Protein ELISA demonstrated to be cost-effective, enabling to shorten the turn around time from one week to 72 hours and gives a swifter testing approach towards emergency runs, Process Performance Qualifications submissions, and deviations initiates by the manufacturing departments. Data has shown that freeze thaw mechanism at -80C extend the shelf life of the assay for up to 3 weeks. Key Terms ⎯ ELISA, Freeze Thaw, Residual Protein Stability.