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  • Testing Service
Testing Service

It is mentioned in the "Clinical Trial Application and Review Standards for Human Cell Therapeutics" that the purpose of quality testing is to verify process control and batch-to-batch consistency, and more importantly, to ensure the quality and safety of the final product. In order to carry out strict quality control on raw materials, reagents and final cell products, UnicoCell established a quality control laboratory (UnicoCell QC Lab), and established analytical methods based on national pharmacopoeias, national standards or scientific journals, and in August 2020 passed the ISO/IEC 17025 inspection by Taiwan Accreditation Foundation (TAF). ISO/IEC 17025 certification items: "sterility test", "endotoxin", "mycoplasma", "cell count and viability.