Quality control of ATMP products are required to guaranty their efficacy and safety, however, they remain at an early stage of development and standardization due to special features of these products. Currently they lack the robustness and harmonization that are characteristics of Quality control assays applied to more established clinical diagnostic and therapeutic treatments.
The External Quality Assessment Programme specific for Advanced Therapies Medicinal Products is a pioneering project worldwide developed by the Cell Manufacture Unit of the Hospital Regional University of Málaga and the biomedical research institute of Málaga (IBIMA) in Spain.
The ultimate goal of the Programme is to guide enrolled participants to be aware of their respective quality controls performance status, through anonymized intercomparison of results. In addition, the program can be a useful tool for the improvement of a given assay.