PROTAC 工程化蛋白/DNA 纳米抗原是癌症免疫治疗中树突状细胞疫苗的有效增强剂
PROTAC-Engineered Protein/DNA Nanoantigen is a Potent Booster for Dendritic Cell Vaccines in Cancer Immunotherapy.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
树突状细胞疫苗作为癌症治疗：聚焦先进治疗药品 13 年生产与质量控制经验
英文原题：Dendritic cell vaccines as cancer treatment: focus on 13 years of manufacturing and quality control experience in advanced therapy medicinal products.
查看英文原题
Dendritic cell vaccines as cancer treatment: focus on 13 years of manufacturing and quality control experience in advanced therapy medicinal products.
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研究概要
我们的研究结果证实，所实施的措施确保了产品的安全性，并有助于建立稳健的“药品质量体系”。这使得许多安全的 mDCs 得以生产用于临床试验。
研究思路结论见上方概要
背景
树突状细胞（DCs）是哺乳动物免疫系统中的专职抗原呈递细胞。体外分化的DCs代表一种独特的先进治疗药品（ATMP），已在多项临床试验中用作个性化癌症免疫治疗。该疗法的可靠性取决于其按照良好生产规范生产高质量成熟DCs（mDCs）的能力。
目的
自2010年3月至2023年12月，共有103名患者入组了IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"免疫基因治疗工厂的多项临床试验。共生产了642剂，并实施了生产工艺优化。我们的研究是一项回顾性分析，重点关注质量控制结果。
方法
我们回顾性分析了每个生产批次所进行的质量控制检测结果，评估了mDCs的活力、纯度和表型，以及其在微生物安全性方面的质量。所得数据以中位数和四分位距表示。
结果
各批次在无菌性、支原体和内毒素方面均显示微生物学安全。发现DC成熟标志物增加。放行标准检查显示，生产过程中维持了高比例的活率和纯度。
展开英文摘要原文
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.
论文信息
- 作者
- Granato AM、Pancisi E、Piccinini C、Stefanelli M、Pignatta S、Soldati V、Carloni S、Fanini F
- 第一作者单位
- Immuno-Gene Therapy Factory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.Italy
- 通讯作者单位
- Experimental and Clinical Oncology Unit of Immunotherapy and Rare Cancers, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy. Electronic address: jenny.bulgarelli@irst.emr.it.Italy
- 文献类型
- 非美国政府资助研究
- 期刊
- Cytotherapy2024 Dec
- 原文标识
- PubMed 39046388 · DOI 10.1016/j.jcyt.2024.07.005