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 (greater than 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.

Speaker: Jay West, Ph.D., Principal Scientist Biologics Process Development – BMS.