生物製藥的即時監測與控制
PAT 實現未來設施
將PAT 融入製造流程有助於建立「生物製程 4.0" 和未來設施的基礎，也就是利用即時監控、控制系統和資料分析，對製藥生產進行全面的數位轉換。有了 PAT，實時製程監控得以實現，提供更深入的製程瞭解、靈活性、彈性以及更完善的品質保證。
Analytical Insights 可改善製程瞭解和產品品質
最近，PAT 通常涉及使用色譜、光譜和/或質譜感測器，這些感測器已整合至上游和下游單元作業中。這些技術可線上、線上或線下使用，以實現製程的實時監測和控制。透過提供即時的洞察力，這些感測器能夠及時進行調整、最佳化和干預，最終達到改善製程瞭解和產品品質的目的。
相關類別
我們的現成與客製化生物製程細胞培養基 (CCM) 產品可提升上游 mAb、疫苗、基因/細胞治療製程的生產力。
Mobius®生物反應器系列包括工作臺規模（2 mL 和 3 L）、中試、臨床和...
使用 Cellicon® Cell Retention Solution 使灌注製程達到更高的細胞密度。
相關網路研討會
利用拉曼光譜監測灌注中的 CPP 和 CQA 的網路研討會。
拉曼光譜如何用於細胞培養基製備的品質控制的網路研討會。
在上游生物製程中，利用自動化無菌取樣加速取得製程與品質資料的網路研討會。
在上游生物製程中，利用自動化無菌取樣加速取得製程與品質資料的網路研討會。
相關影片
相關資源
- 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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