DEVELOPMENT OF ENZYME-LINKED IMMUNOSORBENT ASSAYS (ELISAS) FOR THE DETECTION OF MONOCLONAL-ANTIBODY LEAKAGE FROM IMMUNOAFFINITY CHROMATOGRAPHY MATRICES

Antibodies can leak from immunoaffinity chromatography (IAC) matrices, reducing the working life of the IAC matrix and/or compromising the p urity of the product, purified by IAC, for therapeutic use. There is t herefore a need to monitor the leakage of antibody from IAC matrices. Antibody leakage from a model IAC system was measured using two-site ' non-competitive' ELISAs. Two assays were developed to measure the leak age of intact and fragmented antibody from the IAC matrix. By measurin g the leakage of intact and fragmented antibody the mechanisms underly ing antibody leakage from solid-supports could be elucidated.