Monitoring Virus Aggregates and Drug Substance Concentrations in a TFF Process
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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About the Presenter
Thomas Linke
AstraZeneca
Dr. Thomas Linke is a Principal Scientist in the Department of Purification Process Sciences at AstraZeneca. Since starting at AstraZeneca in 2008, he has worked on pre-clinical through late stage drug development projects. His purification process development experience includes monoclonal antibodies, immunotoxins, antibody drug conjugates, growth factors, vaccines and viral vectors from mammalian and bacterial expression systems. Dr. Thomas Linke graduated from the University of Bonn, Germany, with a Ph.D. in Biochemistry. He completed a postdoctoral fellowship and worked as a staff scientist at the Beltsville Human Nutrition Research Center with a focus on retinol enzymology and applications of proteomics in nutrition research. Prior to joining AstraZeneca, he worked as a process development scientist at Cambrex Biosciences/Lonza with a focus on protein refolding and purification from E. coli inclusion bodies.
