Abstract
News editors obtained the following quote from the background information supplied by the inventors:“Mixing is a critical step in developing drug substances. Low quality of mixing may lead to out-ofspecificationdownstream drug substance and/or wasted capital during the operation. High levels of mixingare required to ensure downstream product quality. This is achieved by mixing inlet streams (e.g. bufferflow, retentate flow, etc.) in a tank while continuously stirring the tank at constant speed using an agitator.The resulting volume exits the tank and goes to the subsequent steps. Several configurations are usuallyutilized to enhance the degree of mixing such as use of internal baffles, placing the agitator at an angleto the tank, use of tangential or radial blades and so on. The quality of mixing, usually represented by“standard deviation” of trace concentration in the tank and in the tank exit, is a complex relationshipof tank geometry, working volume, inlet and outlet configuration and flow rates, agitation speed anddrug substance properties that is typically realized only after long and expensive in-situ studies. In-silicomodels based on computational fluid dynamics (CFD) have been used in order to reduce the cost andtime associated with these studies; however, while resulting in reduced experimentations, CFD modeling isprocessor-intensive, time consuming, and sometimes expensive (e.g., if third party vendors are required).”
NETL
NSTL