树突状细胞（DC）是哺乳动物免疫系统的专业抗原呈递细胞。离体分化的 DC 代表了一种独特的先进治疗药物产品 (ATMP)，在多项临床试验中用作个性化癌症免疫疗法。该疗法的可靠性取决于其生产符合良好生产规范的高质量成熟 DC (mDC) 的能力。从 2010 年 3 月到 2023 年 12 月，IRCCS Istituto Romagnolo 的免疫基因治疗工厂招募了 103 名患者参加多项临床试验根据 Studio dei Tumori (IRST)“Dino Amadori”。生产了六百四十二剂，并实施了制造工艺以优化生产。我们的研究是针对质量控制结果的回顾性分析。我们回顾性分析了每个生产批次进行的质量控制测试的结果，评估 mDC 的活力、纯度和表型及其微生物安全性的质量。获得的数据给出了中位数和四分位数范围。发现这些批次在无菌、支原体和内毒素方面是微生物安全的。发现 DC 成熟标记物增加。放行标准检查显示，生产过程中保持了较高的活力和纯度。我们的调查结果证实，所采取的措施确保了产品的安全性，并有助于建立健全的“药品质量体系”。这使得许多安全的 mDC 能够用于临床试验。版权所有 © 2024 国际细胞学会

Dendritic cells (DCs) are professional antigen-presenting cells of the mammalian immune system. Ex vivo differentiated DCs represent a unique Advanced Therapy Medicinal Product (ATMP), used in several clinical trials as personalized cancer immunotherapy. The therapy's reliability depends on its capacity to produce high-quality mature DCs (mDCs) in compliance with Good Manufacturing Practices.From March 2010 to December 2023, 103 patients were enrolled in multiple clinical trials at the Immuno-Gene Therapy Factory at IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori". Six hundred forty-two doses were produced, and the manufacturing process was implemented to optimize production. Our study is a retrospective analysis focusing on the quality control results.We retrospectively analyzed the results of the quality control tests carried out on each produced batch, evaluating viability, purity and phenotype of mDCs and their quality in terms of microbiological safety. The data obtained are given with median and interquartile range.The batches were found to be microbiologically safe in terms of sterility, mycoplasma, and endotoxins. An increase in DC maturation markers was found. The release criteria checks showed a high percentage of viability and purity was maintained during the production process.Our findings have confirmed that the measures implemented have ensured the safety of the products and have contributed to the establishing a robust "Pharmaceutical Quality System." This has enabled many safe mDCs to be produced for clinical trials.Copyright © 2024 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.