On August 30, 2022 Patrys’ appointed Contract Development Manufacturing Organisation (CDMO) reported that has successfully completed specification testing of PAT-DX1 drug substance produced in the recently-completed engineering run, laying strong foundations for the Company’s planned phase 1 clinical trial next year (Press release, Patrys, AUG 30, 2022, View Source [SID1234618730]).
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Specification, or batch release, testing is a necessary requirement to ensure high quality pharmaceuticals are used in GMP and clinical studies.