POTENCY ASSAY FOR PHARMACEUTICAL PRODUCTS
    27.
    发明公开

    公开(公告)号:EP4386384A1

    公开(公告)日:2024-06-19

    申请号:EP22213839.8

    申请日:2022-12-15

    IPC分类号: G01N33/50

    摘要: The present invention describes a method for assessing the potency of a pharmaceutical product assumed to be effective in treating a disorder, preferably a genetic disorder or a non-genetic disorder, wherein the disorder results in an impaired functionality of a physiological bodily function of a subject having the disorder, wherein the method comprises: (i) incubating an engineered tissue with the pharmaceutical product, wherein the engineered tissue is or has been modified to be representative for the disorder; (ii) determining at least one physical parameter of the engineered tissue resulting from step (i), wherein the physical parameter is a measure of the functionality of the physiological bodily function, and (iii) determining whether a value of the at least one physical parameter determined in step (ii) meets a predetermined threshold of said physical parameter, which determines whether the pharmaceutical product has potency, wherein, if said value of the at least one physical parameter exceeds the predetermined threshold, potency of the pharmaceutical product is indicated for treating the disorder by at least partially restoring the functionality of the physiological bodily function.