Monitoring Virus Aggregates & Drug Substance Concentrations in a TFF Process
On Demand Webinar

Monitoring Virus Aggregates and Drug Substance Concentrations in a TFF Process

On Demand Webinar

Immediate Identification of Agglomeration Mechanisms During Tangential Flow Filtration

During the development of a tangential flow filtration process for an oncolytic virus, the formation of viral aggregates was observed. Inline particle size analysis was performed with EasyViewer, an in-situ image acquisition and analysis instrument, and ParticleTrack, an inline particle size analyzer. The analysis revealed the formation of aggregates greater than 50 micron towards the end of the tangential flow filtration process and the final concentration step. Compared to offline measurements, real-time quantification of particles enables immediate identification of process conditions that lead to aggregation. Drug substance and excipient concentrations were monitored with ReactIR, an in-situ FTIR instrument. The ReactIR instrument allows real-time monitoring of the drug substance concentration during tangential flow filtration by following the intensity of the amide I & II peaks. Furthermore, real-time monitoring of excipients during the tangential flow filtration process has the potential to improve batch to batch consistency of the final drug substance.

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Thomas Linke – Principal Scientist at AstraZeneca
15 minutes