通过流化床离心排序对活性细胞进行分类,使新的培养策略成为可能
Martin Saballus1, Lucas Nik Reger1,2, Robin Obser1
1Sartorius, Corporate Research, Göttingen, Germany.
Frontiers in bioengineering and biotechnology
|October 2, 2025
概括
一种新的流化床离心机 (FBC) 方法有效地分类可活和不可活的细胞,增强生物制药制造. 这种方法增加了细胞活力,提高了抗体标位,并改善了连续培养过程中的时空产量.
科学领域:
- 生物制药制造业 生物制药制造业
- 上游过程强化 上游过程强化
- 细胞培养技术 细胞培养技术
背景情况:
- 连续 perfusion 培养提供高产量,但面临着基于过器的细胞保留的挑战,包括选效应和过器阻塞.
- 目前的方法可以保留不可活性的细胞和有害物质,从而对培养的活力和工艺效率产生负面影响.
- 新的细胞保留策略对于推进下一代连续生物制药制造至关重要.
研究的目的:
- 开发一种大规模的方法来分类可活和不可活的细胞.
- 研究这种分类方法对连续种植策略的适用性.
- 为了解决生物制药制造业当前细胞保留装置的局限性.
主要方法:
- 使用一次性流化床离心机 (FBC) 来分类可活和不可活细胞.
- 实施了一种新的FBC方法,涉及过载的离心机室,用于高通量分类.
- 评估了细胞分类对15毫升和5毫升生物反应器设置后续培养和生产率的影响.
主要成果:
- 细胞分类在食批量培养中增加了+14%的活力和+13%的抗体标位.
- 在5升生物反应器中定期进行细胞分类证明了20天的可行性,实现时空产量为0.75g/L/d.
- 在两个培养试验中,在FBC分类后观察到高达38%的细胞特异性抗体生产率.
结论:
- FBC分类方法有效地去除不可活性的细胞,丰富可活性的细胞并提高培养质量.
- 这种方法与创新的种植概念相结合,克服了持续生物制药制造的当前挑战.
- 流化床离心机分类方法显示出在生物制药行业推进工艺强化方面的巨大潜力.
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