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试点一个用于高质量人类T细胞生产的扩大规模平台。

Piloting a scale-up platform for high-quality human T-cells production.

作者信息

Selvarajan Viknesvaran, Teo Denise Bei Lin, Chang Chaw-Chiea, Ng Yuen Ling, Cheong Nge, Sivalingam Jaichandran, Khoo Soo Hean Gary, Wong Adison, Loo Bernard Liat Wen

机构信息

Food, Chemical and Biotechnology, Singapore Institute of Technology, Singapore, Singapore.

Chemical Engineering, Newcastle University in Singapore, Singapore, Singapore.

出版信息

Front Cell Dev Biol. 2024 Jul 12;12:1427171. doi: 10.3389/fcell.2024.1427171. eCollection 2024.

Abstract

Cell and gene therapies are an innovative solution to various severe diseases and unfulfilled needs. Adoptive cell therapy (ACT), a form of cellular immunotherapies, has been favored in recent years due to the approval of chimeric antigen receptor CAR-T products. Market research indicates that the industry's value is predicted to reach USD 24.4 billion by 2030, with a compound annual growth rate (CAGR) of 21.5%. More importantly, ACT is recognized as the hope and future of effective, personalized cancer treatment for healthcare practitioners and patients worldwide. The significant global momentum of this therapeutic approach underscores the urgent need to establish it as a practical and standardized method. It is essential to understand how cell culture conditions affect the expansion and differentiation of T-cells. However, there are ongoing challenges in ensuring the robustness and reproducibility of the manufacturing process. The current study evaluated various adoptive T-cell culture platforms to achieve large-scale production of several billion cells and high-quality cellular output with minimal cell death. It examined factors such as bioreactor parameters, media, supplements and stimulation. This research addresses the fundamental challenges of scalability and reproducibility in manufacturing, which are essential for making adoptive T-cell therapy an accessible and powerful new class of cancer therapeutics.

摘要

细胞和基因疗法是应对各种严重疾病和未满足需求的创新解决方案。过继性细胞疗法(ACT)作为细胞免疫疗法的一种形式,近年来由于嵌合抗原受体CAR-T产品的获批而受到青睐。市场研究表明,到2030年该行业的价值预计将达到244亿美元,复合年增长率(CAGR)为21.5%。更重要的是,ACT被全球医疗从业者和患者视为有效、个性化癌症治疗的希望和未来。这种治疗方法在全球范围内的巨大发展势头凸显了将其确立为一种实用且标准化方法的迫切需求。了解细胞培养条件如何影响T细胞的扩增和分化至关重要。然而,在确保制造过程的稳健性和可重复性方面仍存在挑战。当前的研究评估了各种过继性T细胞培养平台,以实现数十亿细胞的大规模生产和高质量的细胞产出,同时使细胞死亡降至最低。它研究了生物反应器参数、培养基、补充剂和刺激等因素。这项研究解决了制造过程中可扩展性和可重复性的基本挑战,这对于使过继性T细胞疗法成为一种可及且强大的新型癌症治疗方法至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6aae/11282488/cfd4a44f8181/fcell-12-1427171-g001.jpg

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