The FlowVPX System was used as an in-line instrument for product concentration measurement during UF/DF operations, with orthogonal offline testing done to check comparability. The FlowVPX device has generated significant interest for high concentration UF/DF processes in particular (less than 150 g/L) since overconcentration can result in precipitation. The FlowVPX System has significant potential for GMP and commercial biologics manufacturing with the development of single use flow cells by the vendor. Extensive testing was done using small and pilot scale UF/DF operations with several biologic drugs molecules from the company’s portfolio.  The FlowVPX instrument demonstrated acceptable comparability (within 5% difference) with orthogonal A280 based protein concentration measurements for all molecules tested. Accuracy and precision were equivalent for all flow cells and scales tested, suggesting the FlowVPX can be a robust reliable in-line instrument in GMP settings.

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