Institute of Chemistry and Biotechnology, Zurich University of Applied Sciences, 8820, Wädenswil, Switzerland.
Mares Advanced Therapies, 48268, Greven, Germany.
Appl Microbiol Biotechnol. 2018 May;102(9):3981-3994. doi: 10.1007/s00253-018-8912-x. Epub 2018 Mar 22.
Human mesenchymal stem cell (hMSC)-based therapies are of increasing interest in the field of regenerative medicine. As economic considerations have shown, allogeneic therapy seems to be the most cost-effective method. Standardized procedures based on instrumented single-use bioreactors have been shown to provide billion of cells with consistent product quality and to be superior to traditional expansions in planar cultivation systems. Furthermore, under consideration of the complex nature and requirements of allogeneic hMSC-therapeutics, a new equipment for downstream processing (DSP) was successfully evaluated. This mini-review summarizes both the current state of the hMSC production process and the challenges which have to be taken into account when efficiently producing hMSCs for the clinical scale. Special emphasis is placed on the upstream processing (USP) and DSP operations which cover expansion, harvesting, detachment, separation, washing and concentration steps, and the regulatory demands.
人骨髓间充质干细胞（hMSC）为基础的治疗方法在再生医学领域越来越受到关注。由于经济方面的考虑，同种异体治疗似乎是最具成本效益的方法。基于仪器化一次性生物反应器的标准化程序已被证明可提供数十亿具有一致产品质量的细胞，并优于传统的平面培养系统的扩增。此外，考虑到同种异体 hMSC 治疗的复杂性质和要求，成功评估了一种新的下游加工（DSP）设备。本综述总结了 hMSC 生产工艺的现状，以及在临床规模高效生产 hMSC 时必须考虑的挑战。特别强调了涵盖扩增、收获、分离、分离、洗涤和浓缩步骤以及监管要求的上游处理（USP）和 DSP 操作。
