AVB Sepharose HP Leakage assay

AVB Sepharose HP affinity medium (GE Healthcare) is designed for the purification of Adeno associated virusses (AAV) of several subclasses. The AVB Sepharose HP affinity ligand is based on a single chain antibody fragment that was developed by screening for unique selectivity for AAV of subclasses 1, 2, 3, and 5 (CaptureSelect AAV 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 AAV affinity ligand can leach off of the chromatography support and co-elute with the virus particles. This ELISA provides sensitivity to detect AAV affinity ligand contamination to less than 0.5 ng/ml. This assay is designed to minimize interference and to provide accurate quantitation in the presence of Adeno associated virusses. 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.

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