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 purity of the product, purified by IAC, for therapeutic use. There is therefore 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 leakage of intact and fragmented antibody from the IAC matrix. By measuring the leakage of intact and fragmented antibody the mechanisms underlying antibody leakage from solid-supports could be elucidated.