Process parameter development for the scaled generation of stem cell-derived pancreatic endocrine cells,STEM CELLS Translational Medicine

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Process parameter development for the scaled generation of stem cell-derived pancreatic endocrine cells
STEM CELLS Translational Medicine ( IF 5.4 ) Pub Date : 2021-08-13 , DOI: 10.1002/sctm.21-0161
Diepiriye G Iworima _{1,

2} , Sebastian Rieck ₃ , Timothy J Kieffer _{1,

2,

4}

Affiliation

Diabetes is a debilitating disease characterized by high blood glucose levels. The global prevalence of this disease has been projected to reach 700 million adults by the year 2045. Type 1 diabetes represents about 10% of the reported cases of diabetes. Although islet transplantation can be a highly effective method to treat type 1 diabetes, its widespread application is limited by the paucity of cadaveric donor islets. The use of pluripotent stem cells as an unlimited cell source to generate insulin-producing cells for implant is a promising alternative for treating diabetes. However, to be clinically relevant, it is necessary to manufacture these stem cell-derived cells at sufficient scales. Significant advances have been made in differentiation protocols used to generate stem cell-derived cells capable of reversing diabetes in animal models and for testing in clinical trials. We discuss the potential of both stem cell-derived pancreatic progenitors and more matured insulin-producing cells to treat diabetes. We discuss the need for rigorous bioprocess parameter optimization and identify some critical process parameters and strategies that may influence the critical quality attributes of the cells with the goal of facilitating scalable manufacturing of human pluripotent stem cell-derived pancreatic endocrine cells.

中文翻译：

干细胞衍生胰腺内分泌细胞规模化生成的工艺参数开发

糖尿病是一种以高血糖水平为特征的使人衰弱的疾病。预计到 2045 年，这种疾病的全球患病率将达到 7 亿成年人。1 型糖尿病约占报告的糖尿病病例的 10%。尽管胰岛移植是治疗 1 型糖尿病的一种高效方法，但其广泛应用受到尸体供体胰岛缺乏的限制。使用多能干细胞作为无限的细胞来源来产生用于植入的产生胰岛素的细胞是治疗糖尿病的有希望的替代方案。然而，为了与临床相关，有必要以足够的规模制造这些干细胞衍生细胞。在用于在动物模型中产生能够逆转糖尿病的干细胞衍生细胞和用于临床试验测试的分化方案方面取得了重大进展。我们讨论了干细胞衍生的胰腺祖细胞和更成熟的产生胰岛素的细胞治疗糖尿病的潜力。我们讨论了严格的生物工艺参数优化的必要性，并确定了一些可能影响细胞关键质量属性的关键工艺参数和策略，目的是促进人类多能干细胞衍生胰腺内分泌细胞的可扩展制造。

更新日期：2021-08-13

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