生物工艺前阶段的建模,以优化 perfusion 配置文件和提高过程理解
Aleksandr Pogodaev1, Tanja Hernández Rodríguez2, Mengyao Li1
1Novartis Technical Research & Development, Basel, Switzerland.
Biotechnology and bioengineering
|October 30, 2023
概括
过程建模通过识别理想的 perfusion 配置文件来优化生物过程的前阶段. 这种方法显著减少了中间体消耗和实验工作量,降低了成本,提高了生物制造效率.
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
- 化学工程是化学工程的重要组成部分.
背景情况:
- 生物制药的制造成本很高,影响了市场的可访问性和环境的可持续性.
- 生物处理中的工艺强化对效率至关重要,而前阶段优化最近得到了关注.
- 在生物处理前阶段的输液模式可以实现高细胞密度,但会产生显著的中等成本.
研究的目的:
- 开发一种流程建模方法,以优化生物工艺前阶段的 perfusion profile.
- 为了减少生物制药制造中的中等消费和运营成本.
- 提高生物工艺开发的效率和可预测性.
主要方法:
- 开发和应用一个过程建模策略,以确定最佳的 perfusion 配置文件.
- 在生物工艺开发阶段对模型的内部利用.
- 模型引导与实证 perfusion 策略的比较分析.
主要成果:
- 减少25-45%的透介质体积 (取决于项目).
- 与原始设置相比,最终的细胞密度保持在5%-10%的差异范围内.
- 减少了30%-70%的实验工作量,并使在变化的条件下能够预测最佳配置文件.
结论:
- 过程建模是优化生物工艺前阶段的强大工具.
- 建模指导过程开发,提高效率,降低运营成本.
- 这种方法显著降低了对广泛的湿实验室实验的需求.
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