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The pharmaceutical industry grapples with the persistent challenge of high attrition rates and escalating costs inherent in drugdevelopment. Key techniques include high-throughput screening (HTS), cell-basedassays, and animal models.
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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Cell Based Assays 
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