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cGMP 制造的人诱导多能干细胞可用于临床前和临床应用。

cGMP-Manufactured Human Induced Pluripotent Stem Cells Are Available for Pre-clinical and Clinical Applications.

机构信息

Lonza Walkersville, Inc., Walkersville, MD 21793, USA.

XCell Science, Inc., Novato, CA 94947 USA.

出版信息

Stem Cell Reports. 2015 Oct 13;5(4):647-59. doi: 10.1016/j.stemcr.2015.08.015. Epub 2015 Sep 24.

Abstract

The discovery of induced pluripotent stem cells (iPSCs) and the concurrent development of protocols for their cell-type-specific differentiation have revolutionized our approach to cell therapy. It has now become critical to address the challenges related to the generation of iPSCs under current good manufacturing practice (cGMP) compliant conditions, including tissue sourcing, manufacturing, testing, and storage. Furthermore, regarding the technical challenges, it is very important to keep the costs of manufacturing and testing reasonable and solve logistic hurdles that permit the global distribution of these products. Here we describe our efforts to develop a process for the manufacturing of iPSC master cell banks (MCBs) under cGMPs and announce the availability of such banks.

摘要

诱导多能干细胞(iPSCs)的发现以及针对其细胞类型特异性分化的方案的同时发展,彻底改变了我们对细胞治疗的方法。现在,当务之急是要解决与在符合现行良好生产规范(cGMP)的条件下生成 iPSC 相关的挑战,包括组织来源、生产、测试和储存。此外,关于技术挑战,保持生产和测试成本合理并解决物流障碍,以允许这些产品在全球范围内分发非常重要。在这里,我们描述了我们在 cGMP 下开发 iPSC 主细胞库(MCB)生产工艺的努力,并宣布了此类库的可用性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/373d/4624993/c66f60b53688/gr1.jpg

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