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We support the drug discovery projects of the CCDD with assay development and screening, biophysics, structural biology and recombinant proteinproduction. With all these diverse methods we characterise protein-ligand interactions in many ways. We need to build the assays that we need for compound screening.
For example, in describing how potency should be demonstrated for CGT products, the 2011 guidance simply stated that potency for gene therapy products is derived from “at least two biological activities for its potency: the ability to transfer a genetic sequence to a cell; and the biological effect of the expressed genetic sequence.”
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