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

开发一种优化的封闭式半自动化协议,用于在医院环境中按照良好生产规范制造肿瘤浸润淋巴细胞

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作者:Philippe O Gannon, Alexandre Harari, Aymeric Auger, Clément Murgues, Vincent Zangiacomi, Olivier Rubin, Kim Ellefsen Lavoie, Laurent Guillemot, Blanca Navarro Rodrigo, Tu Nguyen-Ngoc, Sylvie Rusakiewicz, Laetitia Rossier, Caroline Boudousquié, Petra Baumgaertner, Stefan Zimmermann, Lionel Trueb, Ema

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.

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.

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.

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