Expert Consensus on Quality Management of Tumor-Infiltrating Lymphocyte(TIL)Preparation
In recent years,adoptive T cell therapy(ACT)with tumor-infiltrating lymphocyte(TIL)has received much attention.TIL is a new type of lymphocyte with anti-tumor effect which is isolated from tumor tissue,and has the advantages of high efficiency and speci-ficity,low side effects,and has great potential therapeutic value in clinical application.TIL therapy has been developed by several com-panies at home and abroad.LN-144 was approved by US FDA in 2024 for PD-1-resistant advanced melanoma patients,and there is no approved TIL therapy product in China yet.In view of the great heterogeneity in the source,type and production process of TIL cells,and there is no unified national and industry standards on the safety and quality of TIL preparations,such as the requirements of obtaining and transporting tumor tissues,the methods of obtaining purified TIL cells,and the items of product release and testing.Therefore,the estab-lishment of specific TIL preparation standards is of positive significance for ensuring the safety,effectiveness and controllability of TIL preparations.In order to strengthen the quality control of TIL preparation,standardize and guide the quality management of TIL prepara-tion,referring to the relevant documents on immunocyte therapy products and combining the characteristics of TIL cells,the"Expert Con-sensus on Quality Management of Tumor-Infiltrating Lymphocyte(TIL)Preparation"was compiled,in which the quality control elements and quality control technical methods were described according to the key process steps of TIL preparation,so as to provide reference for the formulation of relavant policies on TIL preparation management in China.The background,terminology,production conditions,qual-ity control requirements and testing methods of TIL preparation were defined in this consensus,and the content of production quality man-agement of TIL preparations,such as collection and transportation of tumor tissues,isolation and purification of TIL cells,activation and expansion of TIL cells,release of TIL preparations were emphasized.This consensus is suitable for the quality control of TIL preparations.
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