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IgSelect leakage assay
The IgSelect leakage assay was developed at BAC to quantify the leakage of the IgSelect ligand of the GE Healthcare product. The assay is an easy to use, sensitive ELISA based assay that can be ordered online from this website.
IgSelect affinity medium (GE Healthcare) is designed for the purification of human IgG from different sources. The IgSelect affinity ligand is based on a single chain antibody fragment that was developed by screening for chemical stability and unique selectivity for Fc fragments of human IgG (CaptureSelect Caustic Stable Human IgG Affinity Ligand). The ligand, a 14 kD recombinant protein, is coupled with multipoint attachment through stable amide bonds to give high chemical stability and low leakage. Even when covalently attached, small amounts of the IgSelect affinity ligand can leach off of the chromatography support and co-elute with the antibody. This ELISA provides sensitivity to detect IgSelect affinity ligand contamination to less than 1 ng/mL. This assay is designed to minimize interference and to provide accurate quantitation in the presence of human immunoglobulins. This kit can be used as a tool to aid in optimal purification process development and in routine quality control of in-process streams as well as final product.