一种符合GMP的制造方法,用于沃顿的果衍生中酶体 stromal 细胞
Wanglong Chu1, Fen Zhang1, Xiuping Zeng1
1Shenzhen Beike Biotechnology Co., Ltd, 518000, Shenzhen, Guangdong, People's Republic of China.
Stem cell research & therapy
|May 3, 2024
概括
开发了用于隔离沃顿果衍生的介质干细胞 (WJ-MSCs) 的标准化协议. 优化的酶消化和可扩展的制造确保了再生医学疗法的高产,高质量的WJ-MSC.
科学领域:
- 再生医学是一种再生医学.
- 干细胞生物学 干细胞生物学
- 生物制造 生物制造 生物制造
背景情况:
- 沃顿的果衍生的介质干细胞 (WJ-MSCs) 显示出显著的治疗前景.
- 建立符合良好制造实践 (GMP) 的方法来隔离和培养WJ-MSC是必不可少的.
- 这项研究的重点是开发用于WJ-MSC制造的标准化协议.
研究的目的:
- 为了优化WJ-MSC的隔离和培养协议.
- 为WJ-MSCs开发可扩展的制造工艺.
- 确保WJ-MSCs的高产量和质量.
主要方法:
- 优化的酶消化参数 (酶度,消化时间,播种密度,培养基).
- 将酶性消化与WJ-MSC分离的探索方法进行比较.
- 评估了WJ-MSC通过通道到通道9,并将生产从实验室扩大到试点规模.
- 对药物产品 (DP) 进行了稳定性研究.
主要成果:
- 最佳的酶性消化:0.4 PZ U/mL原酶NB6和3h消化产生了更多的P0 WJ-MSCs.
- 在带组织重量和P0 WJ-MSC量之间观察到正相关性.
- 酶性消化显示出较快的初始WJ-MSC外生比探索方法.
- 段落2-5显示出优越的生存能力和繁殖.
- 成功开发了可扩展的制造工艺.
- 结解周期和DP的不适当解/稀释降低了细胞活力和度.
结论:
- 优化的协议为WJ-MSC隔离和培养提供了宝贵的见解.
- 可扩展的制造工艺使高质量的WJ-MSCs能够大规模生产.
- 这些进展支持基于WJ-MSC的再生医学疗法的进展.
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