Validation of the media fill method for Cytokine-Induced killer cells manufacturing process

Translational Medicine Communications

Research

Aloe Adamini¹  Marco Leone¹  Deborah Rustichelli²  Giuseppe Pinnetta²  Sara Castiglia²  Francesca Sismondi²  Lucia Giordanengo²  Ivana Ferrero²  Alessandra Mandese²  Katia Mareschi³  Franca Fagioli³ 

[1] Department of Science of Public Health and Paediatrics, University of Turin, Piazza Polonia 94, 10126, Turin, Italy;Stem Cell Transplantation and Cellular Therapy Laboratory, Paediatric Onco- Haematology Division, City of Health and Science of Turin, Regina Margherita Children’s Hospital, 10126, Turin, Italy;Stem Cell Transplantation and Cellular Therapy Laboratory, Paediatric Onco- Haematology Division, City of Health and Science of Turin, Regina Margherita Children’s Hospital, 10126, Turin, Italy;Department of Science of Public Health and Paediatrics, University of Turin, Piazza Polonia 94, 10126, Turin, Italy;

关键词: Validation;    Good manufacturing process;    ATMP;   

DOI  :  10.1186/s41231-023-00149-5

 received in 2023-05-10, accepted in 2023-06-27,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundMedia fills are used to demonstrate the adequacy of the aseptic conditions of a pharmaceutical production process, according to good manufacturing practice (GMP), using a growth medium in place of the product solution. For advanced therapy medicinal product (ATMP), where the final product consists of viable cells, the media fill is still a challenge, but represents the starting point for process validation.MethodsThe aim of this paper is to describe the media fill test procedure in the context of ATMP manufacturing, in particular of Cytokine-Induced Killer (CIK) cell expansion process under GMP conditions, including quality control tests and environmental monitoring. The media fill test has been designed to cover all the critical steps of the process, including worst cases and deviations.ResultsFrom July 2019 to August 2022, we performed 16 media fill tests. During these years, the media fill protocol has been gradually improved and the worst cases were designed to be closer to reality and occurring cases. Although some deviations occurred, all the media fills performed were compliant.ConclusionsA good media fill design combined with a robust environmental monitoring program provides a high degree of assurance of the microbial safety of ATMPs.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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