Marco Donia1, Signe Møllebæk Larsen2, Ozcan Met3, Inge Marie Svane4. 1. Center for Cancer Immune Therapy, Department of Hematology, Herlev, Denmark; Department of Oncology, Herlev Hospital, Herlev, Denmark; Department of Bio-medical Sciences, University of Catania, Italy. Electronic address: marco.donia@regionh.dk. 2. Center for Cancer Immune Therapy, Department of Hematology, Herlev, Denmark. 3. Center for Cancer Immune Therapy, Department of Hematology, Herlev, Denmark; Department of Oncology, Herlev Hospital, Herlev, Denmark. 4. Center for Cancer Immune Therapy, Department of Hematology, Herlev, Denmark; Department of Oncology, Herlev Hospital, Herlev, Denmark. Electronic address: inge.marie.svane@regionh.dk.
Abstract
BACKGROUND AIMS: The high level of complexity of current Good Manufacturing Practice-compliant methods of manufacturing hampers rapid and broad application of treatment with tumor-infiltrating lymphocytes (TILs). METHODS: To ensure higher applicability of TIL production to laboratory routine, a practical and simple protocol of TIL manufacturing with the use of a closed-system bioreactor was developed and implemented at our institution. RESULTS: This protocol enabled significant work load reduction during the most labor-intense step of TIL expansion, and allowed generation of high-quality TIL products, which mediated clinical regression in patients with metastatic melanoma. CONCLUSIONS: Implementation of simplified methods of TIL expansion will speed up dissemination of TIL methods worldwide and will increase patient access to this highly effective treatment.
BACKGROUND AIMS: The high level of complexity of current Good Manufacturing Practice-compliant methods of manufacturing hampers rapid and broad application of treatment with tumor-infiltrating lymphocytes (TILs). METHODS: To ensure higher applicability of TIL production to laboratory routine, a practical and simple protocol of TIL manufacturing with the use of a closed-system bioreactor was developed and implemented at our institution. RESULTS: This protocol enabled significant work load reduction during the most labor-intense step of TIL expansion, and allowed generation of high-quality TIL products, which mediated clinical regression in patients with metastatic melanoma. CONCLUSIONS: Implementation of simplified methods of TIL expansion will speed up dissemination of TIL methods worldwide and will increase patient access to this highly effective treatment.
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