使用强化流化床离心平台方法进行成本高效的细胞澄清.
Martin Saballus1, Thomas Josef Filz1, David Pollard2
1Sartorius, Corporate Research, Göttingen, Germany.
Biotechnology and bioengineering
|June 19, 2023
概括
一个新的一次性流化床离心 (FBC) 平台为生物制药制造提供了卓越的抗体回收和成本效益. 这项技术解决了当前方法的瓶,支持加强生物过程和负担得起的患者治疗.
科学领域:
- 生物制药制造业 生物制药制造业
- 工艺工程是过程工程.
- 下游加工 下游加工
背景情况:
- 已建立的生物制造方法,如磁盘堆离心 (DSC) 和深度过 (DF),存在经济和技术限制,包括低生物质容量和产品损失.
- 加强生物制药生产需要先进的细胞澄清技术来克服现有的瓶.
研究的目的:
- 开发和评估一种新型的一次性 (SU) 流化床离心 (FBC) 平台,用于生物制药细胞澄清的集成过.
- 评估FBC在高细胞度 (>100x10^6细胞/毫升) 和其可扩展到200升生物反应器容量的可行性.
- 将FBC方法的经济影响与工业SU生物制造中的传统DSC和DF技术进行比较.
主要方法:
- 开发一种基于SU的新型澄清平台,将FBC与集成过相结合.
- 在高细胞度 (>100x10^6细胞/毫升) 上检测FBC性能.
- 对FBC进行可扩展性测试,以200L生物反应器规模进行中等细胞度的测试.
- 与DSC和DF的FBC的经济比较,每年mAb产量高达500公斤.
主要成果:
- 在高和中等细胞度试验中,实现了低收获度 (4NTU) 和高抗体恢复率 (95%).
- 已证明FBC是500公斤以下年度mAb生产的最具成本效益的解决方案.
- 与既有技术相比,增加细胞度对FBC过程成本的影响最小.
结论:
- 新的SU-FBC平台有效地澄清了高细胞密度的生物制药收获,提供卓越的产品回收和低度.
- FBC为工业生物制造提供了具有成本效益和可扩展性的解决方案,特别是用于强化工艺.
- 这项技术通过克服当前细胞澄清方法的局限性,支持实现负担得起的患者治疗.
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