Measurement of Surfactant Concentration in Viral Vaccine Downstream Processing
Virtual
On Request
On Demand Webinar

Measurement of Surfactant Concentration in Viral Vaccine Downstream Processing

Virtual
On Request
On Demand Webinar

The Use of PAT for Residual Clearance of Surfactant

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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Marina Kirkitadze – Head of Process Support and PAT Platform at Sanofi Pasteur Ltd.
30 minutes
English

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