In-line monitoring of surfactant clearance...

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Presented by

Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur

About this talk

Full Title: In-line monitoring of surfactant clearance in viral vaccine downstream processing The focus of this study is to examine the suitability of in-line infrared measurements to monitor, in real-time, surfactant concentration in a viral vaccine drug substance during a 50KDa tangential flow filtration (TFF) process. An in-line IR probe was used to gather spectra of off-line process samples and reference materials to assess the feasibility of monitoring surfactant concentration during a TFF process in real-time. Both univariate and multivariate models were evaluated using off-line data, and the assessed models were used as validation for a real-time TFF experiment with live process material. Furthermore, experiments using multivariate modelling of process material evaluated by small scale IR experiments, supported the use of multivariate modelling to predict surfactant concentrations between various TFF exchanges. Therefore, results of this study demonstrated the suitability of using an in-line infrared measurement to monitor surfactant concentration in the viral vaccine drug substance during a tangential flow filtration process, and provides insight into creating models that can be further optimized for future in-line use at a manufacturing scale… The topic was presented at other events.

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