PAT：通过实时监控和控制，将质量融入生物制药整体工艺
PAT赋能未来工厂
将PAT纳入制造流程有助于为“生物工艺4.0”和未来工厂奠定基础——所谓未来工厂，即使用实时监控、控制系统和数据分析方法，进行药品生产全面数字化转型。借助PAT，可实现实时过程监控，从而提供改善工艺认识、敏捷性、灵活性和质量保证。
分析见解可改善工艺认识和产品质量
最近，PAT通常涉及在上游和下游运营中引入色谱、光谱和/或质谱传感器。这些技术在线使用，以实时监控和控制工艺。这些传感器可提供实时深度间接，方便及时调整、优化和干预，最终改善工艺认识和产品质量。
相关类别
我们现售和定制生物工艺细胞培养基（CCM）产品可提高上游单抗、疫苗、基因/细胞治疗工艺的产率。
Mobius®生物反应器系列包括台式(2 mL和3 L)、试用、临床级……
通过Cellicon®细胞截留解决方案，帮助灌流工艺实现更高的细胞密度。
相关网络研讨会
关于利用拉曼光谱技术监测灌流工艺CCP和CQA的网络研讨会。
关于利用拉曼光谱技术进行细胞培养基制备质控的网络研讨会。
有关利用自动无菌采样技术加速获取上游生物工艺的工艺和质量数据的网络研讨会。
有关利用自动无菌采样技术加速获取上游生物工艺的工艺和质量数据的网络研讨会。
相关视频
相关资源
- 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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