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首页> 外文会议>General Meeting of European Society of Animal Cell Technology >Manufacturing of Lots of Human T-Lymphocytes for Cell Therapy: A New Process Based on Disposable Bioreactors
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Manufacturing of Lots of Human T-Lymphocytes for Cell Therapy: A New Process Based on Disposable Bioreactors

机译：用于细胞疗法的大量人体T淋巴细胞的制造：一种基于一次性生物反应器的新过程

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About 10 years ago nobody would have believed that cell therapy would become one of the future promises of therapy, and human cells one of the hopes for the cure of emerging diseases not treatable with conventional drugs. The advent and potentiality of stem cells and other types of cells as drugs is revolutionizing the production and regulatory fields. Producer and regulators alike have to be prepared to face with this new concept of therapeutics in terms of cell expansion related to the lot definition, bioreactor used, safety and QC tests for lot release. Here we describe a new process for the GMP manufacturing of human T lymphocytes not HLA restricted, for Phase I and Phase II clinical trials of different types of tumors. The process is based on the use of the modular and disposable bioreactor Cell Factory and was conceived to maximize the potentiality of the bioreactor related to the physiology of the cells. All the steps of the process from MCB thawing to the bags filling are discussed.
机译：大约10年前，没有人会认为细胞疗法将成为治疗的未来承诺之一，人体细胞的一种希望治愈不含常规药物的新兴疾病的希望之一。作为药物的干细胞和其他类型细胞的出现和潜力正在彻底改变生产和监管领域。生产者和监管机构必须在与批次的批次定义，生物反应器，安全性和QC测试相关的细胞扩展方面面对这种新的治疗方法。在这里，我们描述了对不同类型肿瘤的阶段I和II期临床试验的人体T淋巴细胞而不是HLA的GMP制造的新方法。该方法基于使用模块化和一次性生物反应器细胞厂的使用，并构思以最大化生物反应器与细胞生理学相关的潜在性。讨论了从MCB解冻到袋子填充的过程的所有步骤。

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