Process Analytical Technology (PAT) And Data Analytics
Biopharmaceutical production processes have changed significantly due to overall titer improvements and the increasing development of single-use technologies. The introduction of robust and reliable single-use sensors further enhances the benefits of single-use processing concepts. They enable you to use Process Analytical Technology (PAT) approaches for effective automation and optimization.
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Sensors And Process Analyzers
Process analyzers as inline and online measurement technologies provide real-time data for outstanding process control, which results in high-quality production. Thorough monitoring by process analyzers with up to 100% coverage of process parameters and subsequent documentation ensures optimal compliance. Moreover, monitoring makes transactions verifiable and establishes a basis of trust between suppliers and customers.
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Process Automation Platform And Software
Stable and robust processes require sophisticated control of critical process parameters (CPPs) based on reliable data acquisition, storage and evaluation capabilities. State-of the-art process control prevents or mitigates risks of producing faulty batches and represents a further step towards knowledge- and risk-based production of biopharmaceutical products.
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Suite Of Data Analytics Software
Umetrics®
The Umetrics® Suite of data analytics software gives you access to powerful yet easy-to-use tools to optimize your manufacturing processes and bring quality products to market faster. Use the data analytics software to develop robust, high-quality products, continually improve processes and maintain control during manufacturing. These tools support regulatory compliance, enable digital transformation and facilitate quality by design.
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Biomolecule Analysis Tools
In gene therapy and vaccine products, ensuring purity during downstream processing is especially challenging. Fast and efficient tracking of target biomolecules and removal of impurities is critical, because it directly affects product yield and purity. Sartorius‘ analytical chromatography column solutions can help provide this information in real-time, through at-line monitoring of large biomolecules including viruses, pDNA, and mRNA.
