In-line monitoring of surfactant clearance in viral vaccine downstream processing



15th February 2022 | 10:00am EST | Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur |WATCH FOR FREE
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.
Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur

Marina Kirkitadze is Head of Process Support and PAT Platform, Analytical Sciences North America, Sanofi Pasteur Ltd., Toronto Canada.  She has 19 years of experience in the vaccine industry. Marina received her PhD in Biological Sciences at the Institute of Protein Research, Russian Academy of Sciences, Pushchino, Russia, and her MBA from the University of Phoenix, AZ, USA. Prior to joining Sanofi Pasteur, Marina was a postdoctoral fellow at the Department of Chemistry, University of Edinburgh, and then at the Center for Neurological Diseases, Brigham and Women’s Hospital and Harvard Medical School. Marina’s focus is on the development and implementation of PAT solutions for in-line monitoring of media components, protein concentration and conformation, process-related residuals, and protein adsorption. Her contributions went towards the CMC section in eBLA application for Adacel, approvals for the new manufacturing facility and its extension, Pentacel, and to Module 3 CTD of Hexaxim vaccine submission. Marina has published 40 manuscripts

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