Bioprocessing Downstream Applications
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Tangential Flow Filtration TFF systems are employed in downstream processes to purify, concentrate, and formulate drug substances e.g., mAb’s. TFF consists of ultrafiltration and diafiltration (UFDF) steps.
KxS DCM-20 is a proven PAT sensor installed directly in the TFF system and collection tank. Process data is captured continuously and visualized as live concentration trend, accessible directly via the user interface. A measurement accuracy of ±0.5 mg/mL can be achieved in full range 0-300 mg/ml.
During ultrafiltration UF, DCM-20 tracks the rising concentration profile in real-time and gives a distinct end-point detection of the batch.
During diafiltration DF, DCM-20 confirms that protein concentration remains stable and within specifications across the entire buffer exchange.
Real-time release testing (RTRT) is redefining quality assurance in pharmaceutical manufacturing. By integrating inline PAT tools, automation, and data analytics, RTRT enables continuous monitoring and control of critical process parameters, replacing end-of-batch offline testing with real-time, data-driven batch release. The result is reduced manufacturing cycle time, data-driven batch control, and full regulatory traceability throughout production.
KxS Process refractometer DCM-20 with Ingold connection is a proven Process Analytical Technology (PAT) sensor for monitoring protein concentrations directly in Tangential flow filtration (TFF) systems and their collection tanks. The continuous data generated by KxS inline refractometer directly supports Quality by Design (QbD) and Real Time Release Testing (RTRT) frameworks, providing validated, real-time process data needed for timely release of the production batches.
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