DEVELOPMENT OF ENZYME-LINKED IMMUNOSORBENT ASSAYS (ELISAS) FOR THE DETECTION OF MONOCLONAL-ANTIBODY LEAKAGE FROM IMMUNOAFFINITY CHROMATOGRAPHY MATRICES
Dj. Beer et al., DEVELOPMENT OF ENZYME-LINKED IMMUNOSORBENT ASSAYS (ELISAS) FOR THE DETECTION OF MONOCLONAL-ANTIBODY LEAKAGE FROM IMMUNOAFFINITY CHROMATOGRAPHY MATRICES, Journal of immunological methods, 173(1), 1994, pp. 103-109
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.