Implementation of Raman Spectroscopy for in-line monitoring of critical process parameters of CHO cell perfusion cultures

Process Analytical Technology (PAT) is a regulatory framework initiated by the United States’ Food and Drug Administration (FDA) that encourages innovation in pharmaceutical development, manufacturing, and quality assurance. The goal of PAT is to build quality into biopharmaceutical production processes by monitoring and controlling the process in real time.

Through the identification and monitoring of critical process parameters (CPP) and critical quality attributes (CQA) within a specified design space, Raman spectroscopy enables understanding of cell culture processes and improvement of product quality by real-time monitoring. Rather than measuring the quality by testing, we are incorporating quality into the design of the process, making it more robust and transparent.


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