Lonza Cologne GmbH, Cologne,, Germany,
Adv Biochem Eng Biotechnol. 2014;138:61-97. doi: 10.1007/10_2013_233.
: Human primary cells (e.g. adult stem cells) as well as differentiated cells, including those of the immune system, have been found to be therapeutically useful and free of ethical concerns. Several products have received market authorization and numerous promising clinical trials are underway. We believe that such primary therapeutic cells will dominate the market for cell therapy applications for the foreseeable future. Consequently, production of such cellular products warrants attention and needs to be a fully controlled pharmaceutical process. Thus, where possible, such production should change from manufacture towards a truly scalable industrialized process for both allogeneic and autologous products. Here, we discuss manufacturing aspects of both autogeneic and allogeneic products, review the field, and provide historical context.
: 已发现人类原代细胞（例如成体干细胞）和分化细胞，包括免疫系统细胞，具有治疗用途且不存在伦理问题。已有若干产品获得市场许可，并且许多有前途的临床试验正在进行中。我们相信，在可预见的未来，此类原代治疗细胞将主导细胞治疗应用市场。因此，此类细胞产品的生产值得关注，并且需要成为一个完全受控制的药物生产过程。因此，在可能的情况下，此类生产应从制造转变为真正可扩展的同种异体和自体产品的工业化过程。在这里，我们讨论了自体和同种异体产品的制造方面，综述了该领域，并提供了历史背景。
