An evaluation of a beta version of the FlowVPX and Viper software was performed to determine it’s potential as an inline instrument for product concentration measurement during UF/DF operation, particularly high concentration UF/DF processes that are required for subcutaneous injection formulations (>150 g/L). The FlowVPX has significant potential for GMP and commercial biologics manufacturing unlike the first generation FlowVPE, which was designed as a lab scale instrument. Extensive testing was done using small and pilot scale UF/DF operations with several biologic drugs molecules from the portfolio. The FlowVPX instrument demonstrated very good comparability with other A280 based protein concentration measurements for all molecules tested (six). From a technical standpoint the FlowVPX is a GMP ready instrument, and further testing for instrument robustness and software development is ongoing at present to potentially use the instrument in the GMP space within the near future.
About the speaker
Jay West is Principal Scientist at Bristol Myers Squibb in the Process Development Analytics group in Devens, MA. He obtained his BS in Chemistry from Rensselaer, MS in Chemistry from University at Albany, PhD in Biochemistry from Boston College, and performed postdoctoral research at Northeastern University. He has 10 years pharmaceutical industry experience, working at Regeneron Pharmaceuticals in clinical manufacturing before starting a PhD, and joining BMS in 2014 as an analytical scientist. His focus the past four years has been on Process Analytical Technology, focusing on applications for downstream biologics process development.