首页> 美国卫生研究院文献>Journal of Translational Medicine >Cytokines induced killer cells produced in good manufacturing practices conditions: identification of the most advantageous and safest expansion method in terms of viability cellular growth and identity
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Cytokines induced killer cells produced in good manufacturing practices conditions: identification of the most advantageous and safest expansion method in terms of viability cellular growth and identity

机译:在良好的生产实践条件下生产的细胞因子诱导的杀伤细胞:在生存力细胞生长和特性方面确定最有利和最安全的扩增方法

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摘要

BackgroundCytokine-induced killer (CIK) cells are a very promising cell population raising growing interest in the field of cellular antitumor therapy. The aim of our study was to validate the most advantageous expansion method for this advanced therapy medicinal product (ATMP) and to translate it from preclinical field to good manufacturing practices (GMP). GMP ensures that ATMP are consistently produced and controlled to the quality standards required to their intended use. For this reason, the use of the xenogenic sera tended to be minimized by GMP for their high variability and the associated risk of transmitting infectious agents.
机译:背景细胞因子诱导的杀伤(CIK)细胞是非常有前途的细胞群体,引起了细胞抗肿瘤治疗领域的日益增长的兴趣。我们研究的目的是验证这种先进治疗药物(ATMP)的最有利扩展方法,并将其从临床前领域转化为良好生产规范(GMP)。 GMP确保始终如一地生产和控制ATMP,以达到其预期用途所需的质量标准。因此,由于GMP的高变异性和相关的传染病传播风险,GMP倾向于将异种血清的使用减至最少。

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