下游加工中的传感器和化学计量
Astrid Dürauer1, Alois Jungbauer1,2, Theresa Scharl3
1Institute of Bioprocessing Science and Engineering, University of Natural Resources and Life Sciences, Vienna, Austria.
Biotechnology and bioengineering
|July 20, 2023
概括
生物制药制造正在向自动化,自主化的过程过渡. 集成软传感器和预测化学测量可以实时监测和控制强大的生物制造.
科学领域:
- 生物制药制造业 生物制药制造业
- 过程控制 过程控制
- 化学测量 化学测量 化学测量
背景情况:
- 生物制药行业传统上以批量模式运作,因为严格的法规和依赖离线质量控制.
- 关键的产品质量属性包括数量,纯度,功效,以及没有偶然的剂和生物负担.
- 一次性使用技术和综合生物处理等新兴趋势正在塑造生物制造的未来.
研究的目的:
- 审查自动化和自主化生物处理的步骤,重点关注监测和控制策略.
- 探索用于现代过程控制的软传感器和预测化学测量的集成.
- 证明这些概念在下游生物制药加工中的应用.
主要方法:
- 审查当前的生物处理实践和监管举措 (过程分析技术,设计质量,连续集成制造).
- 使用软传感器逐步整合实时监控的概念.
- 应用统计工具,如多变量统计和神经网络,用于模型训练.
主要成果:
- 软传感器为将实时监控集成到生物处理中提供了一种可行的方法.
- 预测化学测量,结合软传感器,可以增强过程控制.
- 在下游加工步骤中成功应用,如染色学和膜过.
结论:
- 自动化和自主生物处理是生物制药行业可实现的目标.
- 软传感器和预测化学测量是实时释放和强大的生物制造的关键推动因素.
- 这些技术的逐步实施将导致高度预测和高效的生物制造系统.
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