生物制药中的实时监测与控制

PAT技术助力未来工厂建设
将PAT技术融入生产流程,为"生物加工4.0"及未来工厂奠定基础——这意味着通过实时监测、控制系统与数据分析实现制药生产的全面数字化转型。PAT技术赋能实时工艺监控,提升工艺认知深度,增强生产敏捷性与灵活性,并强化质量保障体系。
分析洞察力提升工艺理解与产品质量
近年来,过程分析技术(PAT)通常采用色谱、光谱和/或质谱传感器,将其集成于上游和下游单元操作中。这些技术通过在线、联线或旁线方式应用,实现对工艺的实时监测与控制。通过提供实时洞察,这些传感器支持及时调整、优化和干预,最终提升工艺理解水平并改善产品质量。
相关分类
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相关资源
- White Paper: Workforce 4.0: The Long-Term Success of the Biopharmaceutical Industry
A public-private approach to workforce 4.0 development, transitioning from conventional factories to “smart” manufacturing facilities.
- Application Note: In-Line Monitoring of CPPs and Capsid Titer in Upstream AAV Process with ProCellics™ Raman Analyzer
Explore the ProCellics™ Raman Analyzer for in-line monitoring of critical process parameters (CPPs) and capsid titer during AAV production in Human Embryonic Kidney (HEK) cell bioreactors.
- Application Note: In-line Real-time Monitoring of CHO Cell Culture Process Parameters Using Raman Spectroscopy
Cell culture processes are complex and highly variable and yet only a handful of key parameters such as temperature, pH, and dissolved oxygen (DO) are typically controlled in real time.
- Application Note: Implementation of Raman Spectroscopy for In-line Monitoring of CPPs of CHO Cell Perfusion Cultures
This application note introduces a case study for the implementation of a Raman spectroscopy soft-sensor for in-line and real-time monitoring of critical process parameters (CPP) in mammalian perfusion cell cultures.
- Application Note: Seamless Integration of Glucose Control Using Raman Spectroscopy in CHO Cell Cultures
Process analytical technology (PAT) and quality by design (QbD) are used in the biopharmaceutical industry to ensure quality is designed into a process and to achieve innovative quality improvements.
- Article: Influence of Cell Specific Parameters in a Dielectric Spectroscopy Conversion Model Used to Monitor Viable Cell Density in Bioreactors
In the biopharmaceutical industry, the use of mammalian cells to produce therapeutic proteins is becoming increasingly widespread. Monitoring of these cultures via different analysis techniques is essential to ensure a good quality product while respecting good manufacturing practice (GMP) regulations.
- White Paper: Automated Aseptic Sampling for Accelerated Access to Process and Quality Data in Upstream Bioprocessing
The biopharmaceutical market is experiencing increased demand for new medicines, reduction of costs, and new product classes, which is driving the need for increased flexibility and cost control measures in manufacturing.
- Data Sheet: MAST® Autosampling Solution
Current off-line sampling methods often present challenges related to sample source contamination, inadequate sample traceability and delivery, lengthy experimental turnaround times, and inconsistent results.
- Brochure: Process Development and Drug Manufacturing: Support Services
We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.
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