开发一种超强化的料批细胞培养工艺,大大提高了性能和生产率
Shaoxun Xiang1, Jinliang Zhang1, Le Yu1
1Process Development, WuXi Biologics, Wuxi, China.
Biotechnology and bioengineering
|November 23, 2023
概括
一种新的间歇性输液养批次 (IPFB) 过程改善了细胞培养性能,在CHO细胞中提高了45%的生产率. 超强化的IPFB实现了高达6倍的产量,降低了成本并证明了可扩展性.
科学领域:
- 生物技术是生物技术.
- 生物工艺工程 生物工艺工程
- 细胞培养技术 细胞培养技术
背景情况:
- 强化养批量 (IFB) 是提高细胞培养生产率的常见策略.
- 然而,IFB可以导致亡的增加和不可持续的生产力.
- 需要改进细胞培养过程,提高生产率,同时保持细胞活力.
研究的目的:
- 开发和评估一种新的间歇性 perfusion-fed-batch (IPFB) 过程.
- 调查超强化IPFB (UI-IPFB) 对进一步提高生产率的潜力.
- 评估这些新过程的可行性,可扩展性和成本效益.
主要方法:
- 通过将间歇性 perfusion 循环纳入 IFB 开发了 IPFB.
- 设计的UI-IPFB具有显著更高的播种密度,使用交替接触流 (ATF) 过.
- 在多重重组合中国仓鼠卵巢 (CHO) 细胞系和产品中评估IPFB和UI-IPFB.
主要成果:
- 与IFB相比,IPFB在八个CHO细胞系中显示出平均标位增加约45%,与IFB相比.
- UI-IPFB的生产率高达传统料批次的6倍,高达IFB的3倍.
- 这两种过程都显示出广泛的可行性,成本降低和可扩展性.
结论:
- IPFB为持续的细胞和代谢行为提供了可行的策略,从而提高了生产力.
- UI-IPFB代表了细胞培养强化方面的重大进步,实现了前所未有的产量.
- 这些新的工艺是有效的,可扩展的,并降低生物制药制造的商品成本.
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