Marina Kirkitadze Ph.D, MBA is Head of Process Support and PAT Platform, Analytical Sciences North America at Sanofi Pasteur Ltd. She has over 19 years 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. Prior to joining Sanofi Pasteur, Marina was a postdoctoral fellow at the Department of Chemistry, University of Edinburgh, and then at Center for Neurological Diseases, Brigham and Women’s Hospital and Harvard Medical School. Marina’s focus is on development and implementation of PAT solutions for inline monitoring of media components, protein concentration and conformation, process-related residuals, and protein adsorption. Her contributions went towards CMC section in eBLA application for Adacel, approvals for new manufacturing facility and its extension, Pentacel, and to Module 3 CTD of Hexaxim vaccine submission. Marina has published 41 manuscripts.
In this presentation, Marina Kirkitadze, Head of Process Support and PAT Platform at Sanofi Pasteur Ltd. reviews the use of Process Analytical Technology (PAT) for surfactant modelling and quantification.
An inline IR probe was used to gather spectra of process offline 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 used to evaluate the offline sample data and were found to be in good agreement with surfactant concentration values obtained by HPLC. These results were used as justification for a real-time TFF experiment with live process material.
Small scale IR experiments with process material demonstrated that a multivariate model using the 1300 cm-1 to 1000 cm-1 spectral region can be used to predict surfactant concentrations between TFF exchanges 8 to 15. The results of this study demonstrated suitability of an inline infrared measurement to monitor surfactant concentration in the viral vaccine drug substance between exchanges 8-15 of a 50kDa tangential flow filtration process. The preliminary multivariate model used for this work can be further optimized for the inline use at manufacturing scale.
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