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优化免疫细胞治疗生产中的病毒转导:关键工艺设计考量

Optimizing viral transduction in immune cell therapy manufacturing: key process design considerations.

作者信息

Dan Liu, Kang-Zheng Lee

机构信息

Bioprocessing Technology Institute BTI, Agency for Science, Technology and Research (A*STAR), 20 Biopolis Way, Singapore, 138668, Singapore.

出版信息

J Transl Med. 2025 May 2;23(1):501. doi: 10.1186/s12967-025-06524-0.

DOI:10.1186/s12967-025-06524-0
PMID:40316943
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12046913/
Abstract

Immune cell therapies have revolutionized the treatment of cancers, autoimmune disorders, and infectious diseases. A critical step in their manufacturing is viral transduction, which enables the delivery of therapeutic genes into immune cells. However, the complexity of this process presents significant challenges for optimization and scalability. This review provides a comprehensive analysis of viral transduction process in immune cell therapy manufacturing, highlighting key design considerations to support the development of safe, effective, and scalable production methods. Additionally, it examines current technological challenges in immune cell transduction and explores future innovations poised to advance the field.

摘要

免疫细胞疗法彻底改变了癌症、自身免疫性疾病和传染病的治疗方式。其生产过程中的一个关键步骤是病毒转导,它能将治疗性基因导入免疫细胞。然而,这一过程的复杂性给优化和扩大规模带来了重大挑战。本文综述对免疫细胞治疗生产中的病毒转导过程进行了全面分析,强调了关键的设计考量因素,以支持安全、有效且可扩展的生产方法的开发。此外,还研究了免疫细胞转导当前的技术挑战,并探索了有望推动该领域发展的未来创新。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f2e/12046913/c1f1efe64a06/12967_2025_6524_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f2e/12046913/c1f1efe64a06/12967_2025_6524_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f2e/12046913/c1f1efe64a06/12967_2025_6524_Fig1_HTML.jpg

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J Control Release. 2025 May 10;381:113561. doi: 10.1016/j.jconrel.2025.02.057. Epub 2025 Feb 22.
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The design of retroviral vectors used in the CAR-T products, risk management, and future perspective.嵌合抗原受体T细胞(CAR-T)产品中使用的逆转录病毒载体设计、风险管理及未来展望。
MedComm (2020). 2025 Jan 24;6(2):e70067. doi: 10.1002/mco2.70067. eCollection 2025 Feb.
3
From ex vivo to in vivo chimeric antigen T cells manufacturing: new horizons for CAR T-cell based therapy.
从体外到体内嵌合抗原T细胞制造:基于CAR-T细胞疗法的新视野
J Transl Med. 2025 Jan 4;23(1):10. doi: 10.1186/s12967-024-06052-3.
4
Research Status and Applications of Adeno-Associated Virus.腺相关病毒的研究现状与应用
Chembiochem. 2025 Apr 1;26(7):e202400856. doi: 10.1002/cbic.202400856. Epub 2025 Jan 9.
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Efficient manufacturing of CAR-T cells from whole blood: a scalable approach to reduce costs and enhance accessibility in cancer therapy.从全血高效制造嵌合抗原受体T细胞(CAR-T细胞):一种降低成本并提高癌症治疗可及性的可扩展方法。
Cytotherapy. 2025 Mar;27(3):400-409. doi: 10.1016/j.jcyt.2024.11.013. Epub 2024 Dec 8.
6
Strategies for Modifying Adenoviral Vectors for Gene Therapy.腺病毒载体基因治疗的修饰策略。
Int J Mol Sci. 2024 Nov 20;25(22):12461. doi: 10.3390/ijms252212461.
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Optimizing the procedure for manufacturing clinical-grade genetically manipulated natural killer cells for adoptive immunotherapy.优化用于过继性免疫治疗的临床级基因工程改造自然杀伤细胞的制造程序。
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Automated and closed clinical-grade manufacturing protocol produces potent NK cells against neuroblastoma cells and AML blasts.自动化且封闭的临床级制造方案可生成针对神经母细胞瘤细胞和 AML 原始细胞的强效 NK 细胞。
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