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The MultiBac Protein Complex Production Platform at the EMBL
Published on: July 11, 2013
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一个模块化和多功能净化策略,为制造规模的综合和连续生物制造提供一个共同的框架
Leon P Pybus1, Charles Heise1, Tibor Nagy1
1Process Development, FUJIFILM Diosynth Biotechnologies, Billingham, UK.
Biotechnology progress
|March 18, 2024
概括
综合和连续生物制造 (ICB) 正在推进SymphonXTM,这是一个新的下游加工滑板. 该系统可实现生物制药生产的灵活,插即用操作,证明一致的质量和生物负担控制.
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:
- 生物制药制造正在从传统的批量工艺转向综合和连续生物制造 (ICB).
- 由于复杂的供应链,依赖定制的一次性组件和广泛的缓冲器要求,实现ICB的全部潜力是具有挑战性的.
- 现有的商业设备往往难以满足综合,多供应商系统的需求.
研究的目的:
- 引入和评估SymphonXTM,这是一种新的下游处理滑道,旨在克服ICB中的挑战.
- 为了证明SymphonXTM对灵活,多产品和多工艺cGMP (当前良好制造实践) 设施的能力.
- 在ICB的制造规模概念验证中验证SymphonXTM的性能.
主要方法:
- 开发SymphonXTM滑板,具有先进的缓冲器管理,单一的通用一次性流量路径和统一的接口.
- 在稳态 perfusion 生物反应器中使用 ApolloTM X CHO-DG44 mAb 表达细胞系,用于连续的产品采集.
- 使用SymphonXTM实现下游处理,使用单列染色学 (蛋白A,离子交换,离子交换) 和批量病毒失活,在单位操作之间使用冲压容器.
主要成果:
- 成功连续采集和处理单克隆抗体 (mAb) 产品6天.
- 每天生产0.54公斤药物质,具有一致的产品质量属性.
- 在连续运行模式下运行的单位运营中证明有效的生物负担控制.
结论:
- SymphonXTM提供了一个灵活而强大的平台,用于集成和连续的生物制造.
- 该系统促进了插件运行操作,降低了运营风险,并使多产品功能成为可能.
- 这项研究验证了制造规模ICB的可行性,同时保持一致的产品质量和生物负担控制.
关键词:
中国仓鼠的卵巢下游加工是下游加工.综合和连续的生物制造.mAb生物处理 mAb生物处理perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion perfusion 这是一个非常重要的方法,它可以让一个人觉得自己是个好的人,而不是一个好的人,而是一个好的人.在上游加工过程中.
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