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The CaptureSelect™ VIISelect Leakage ELISA detects VIISelect affinity ligand contamination of human recombinant Factor VII purified using VIISelect affinity resin (GE Healthcare). Even when covalently attached, small amounts of the VIISelect affinity ligand can leach off of the chromatography support and co-elute with the purified product. This ELISA provides sensitivity to detect VIISelect affinity ligand contamination of less than 1 ng/mL. The assay is designed to minimize interference and to provide accurate quantitation in the presence of Factor VII and other proteins. The CaptureSelect™ VIISelect Leakage ELISA 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.
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