在不连续的抗体生物制造中,通过结合协同的过程强化策略来实现三倍的时空收益率
Lucas Nik Reger1,2, Martin Saballus1, Markus Kampmann1
1Corporate Research, Sartorius, 37079 Göttingen, Germany.
Bioengineering (Basel, Switzerland)
|December 23, 2023
概括
这项研究引入了一种用于治疗分子的新型不连续生物制造工艺. 增加注射密度和媒介交换的结合大大提高了生产率,减少了过程时间,为标准方法提供了灵活的替代方案.
科学领域:
- 生物技术是生物技术.
- 生物制药制造业 生物制药制造业
- 过程强化 过程强化
背景情况:
- 单克隆抗体是关键的治疗药物,需要高效和可扩展的生产.
- 随着COVID-19的流行,人们需要更灵活,更高效的生物制造工艺.
- 目前的生产方法在满足全球治疗分子需求快速增长方面面临挑战.
研究的目的:
- 设计和评估治疗分子的新型不连续生物制造工艺.
- 为了结合工艺强化策略,特别是增加注射密度和使用流化床离心机进行介质交换.
- 评估这些策略对工艺持续时间,产品形成,时空产量和产品质量的影响.
主要方法:
- 设计了一种新的不连续工艺,通过集成增加的注射密度和媒介交换通过流化床离心机.
- 进行了小规模的实验,以验证强化策略之间的协同效应.
- 该过程被扩展到概念验证规模,以验证性能.
主要成果:
- 综合强化策略的结果是,工艺持续时间减少了37%.
- 与标准操作相比,产品形成显著提高了116%.
- 实现了时空产量的三倍增长,对产品质量的影响微不足道.
结论:
- 新的不连续工艺为治疗分子制造提供了灵活和高生产率的替代方案.
- 这种强化过程显示出与标准料批运作相比的显著改进.
- 该过程提高了生物制造能力,这对于应对需求增加和紧急情况至关重要.
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