The new gold standard for gene therapy protein expression potency measurements

A lack of fit-for-purpose potency assays is posing a significant challenge that delays transformative gene therapies from reaching patients, especially when scaling from discovery and development to regulatory approval. These assays are some of the most important in an analytical toolbox but are often the most high-risk and complex.

Simple Western™ automates protein expression analysis in cell and tissue lysates, accelerating gene therapy development that scales seamlessly from preclinical research to product release. As a platform technology that needs only a single validated antibody and offers rapid 3-hour runtimes. Simple Western lowers the custom assay development hurdles of ELISA. Plus, Simple Western is a multi-attribute method used in gene therapy development, beyond protein expression potency assays, for quantitative CQA monitoring of purity, titer, empty/full capsid content, and capsid protein ratio. In this application note, Bio-Techne demonstrates a Simple Western relative potency assay with analytical-grade protein expression quantification for AAV-mediated gene delivery in cultured human cells.

The New Gold Standard for Gene Therapy Protein Expression Potency Measurements (1)

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