Cook General Biotechnology LLC, Indianapolis, IN 46202, USA.
Expert Opin Biol Ther. 2013 May;13(5):673-91. doi: 10.1517/14712598.2013.763925. Epub 2013 Jan 23.
Mesenchymal stem cells (MSC) and MSC-like cells hold great promise and offer many advantages for developing effective cellular therapeutics. Current trends indicate that the clinical application of MSC will continue to increase markedly. For clinical applications, large numbers of MSC are usually required, ideally in an off-the-shelf format, thus requiring extensive MSC expansion ex vivo and subsequent cryopreservation and banking.
To exploit the full potential of MSC for cell-based therapies requires overcoming significant cell-manufacturing, banking and regulatory challenges. The current review will focus on the identification of optimal cell source for MSC, the techniques for production scale-up, cryopreservation and banking and the regulatory challenges involved.
There has been considerable success manufacturing and cryopreserving MSC at laboratory scale. Surprisingly little attention, however, has been given to translate these technologies to an industrial scale. The development of cost-effective advanced technologies for producing and cryopreserving commercial-scale MSC is important for successful clinical cell therapy.
间充质干细胞（MSC）和 MSC 样细胞具有巨大的潜力，并为开发有效的细胞治疗提供了许多优势。目前的趋势表明，MSC 的临床应用将继续显著增加。对于临床应用，通常需要大量的 MSC，理想情况下是以现成的形式，因此需要在体外进行广泛的 MSC 扩增，然后进行冷冻保存和储存。
要充分发挥 MSC 在细胞治疗中的潜力，需要克服重大的细胞制造、储存和监管挑战。本综述将重点介绍用于 MSC 的最佳细胞来源的鉴定、生产规模扩大的技术、冷冻保存和储存以及涉及的监管挑战。
在实验室规模上制造和冷冻保存 MSC 已经取得了相当大的成功。然而，令人惊讶的是，人们很少关注将这些技术转化为工业规模。开发经济高效的先进技术来生产和冷冻保存商业规模的 MSC 对于成功的临床细胞治疗非常重要。
