生物制药中的实时监测与控制

PAT助力未来设备
将PAT融入生产流程有助于为 "生物加工 4.0 "和 "未来设施 "奠定基础。0 "和 "未来设施 "的基础,即利用实时监测、控制系统和数据分析对制药生产进行全面的数字化改造。有了 PAT,就能实现实时工艺监控,从而更好地了解工艺,提高灵活性和柔性,并改进质量保证。
分析洞察力可提高对工艺的理解和产品质量
最近,PAT 通常涉及使用色谱、光谱和/或质谱传感器,并将其集成到上游和下游单元操作中。这些技术可在线、在线或在线使用,以实现对工艺的实时监测和控制。通过提供实时见解,这些传感器能够及时调整、优化和干预,最终提高对工艺的理解和产品质量。
相关类别
我们的现成和可定制的生物加工细胞培养基 (CCM) 产品可提高上游 mAb、疫苗、基因/细胞治疗工艺的生产率。
Mobius®生物反应器系列包括台架规模(2 mL 和 3 L)、中试规模、临床规模和实验室规模。
利用 Cellicon® 细胞保持解决方案,使灌注过程实现更高的细胞密度。
相关资源
- 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.
询问 PAT 专家
BioContinuum™平台:未来生物制造设施的推动者!

如要继续阅读,请登录或创建帐户。
暂无帐户?