Development of an optimized closed and semi-automatic protocol for Good Manufacturing Practice manufacturing of tumor-infiltrating lymphocytes in a hospital environment.

Abstract Background aims Several studies report on Good Manufacturing Process (GMP)-compliant manufacturing protocols for the ex vivo expansion of tumor-infiltrating lymphocytes (TILs) for the treatment of patients with refractory melanoma and other solid malignancies. Further opportunities for improvements in terms of ergonomy and operating time have been identified. Methods To enable GMP-compliant TILs production for adoptive cell therapy needs, a simple automated and reproducible protocol for TILs manufacturing with the use of a closed system was developed and implemented at the authors’ institution. Results This protocol enabled significant operating time reduction during TILs expansion while allowing the generation of high-quality TILs products. Conclusions A simplified and efficient method of TILs expansion will enable the broadening of individualized tumor therapy and will increase patients’ access to state-of-the-art TILs adoptive cell therapy treatment.