Antibodies and Therapeutics

Biography

Biography: William George Whitford,

Abstract

Upstream continuous bioprocessing (CB) is supported by number of approaches to perfusion culture. Coincident with a growing interest in CB are continuing developments in single-use (SU) processing and cell-culture media design. SU perfusion-capable equipment is now available to support many types of process flexibilities, increased facility utilization as well as reduced CapEx, OpEx and build times. Such advanced SU systems support a high degree of flexibility in process flow and configuration, component types, physical location and production mode. As animal-cell platforms are adapted to perfusion culture in such facilities, the need for media and feeds optimized for intensified processes involving perfusion in SU equipment has become apparent. Renewed discussions appearing on the relative value of powder vs bulk liquid supply are based upon perfusion-based operation, higher specific productivities, regional manufacturing and improved shipping/packaging technologies. Formulation goals are being achieved through the implementation of such new development tools as HTS, ‘omics capabilities, chemometrics and metabolic flux analysis. The above activities support the ultimate goal of real-time, continuous quality and process verification in pre-engineered, modular and turn-key multi-product manufacturing facilities. For many platforms, such designs can also be imagined in either ready-to-use, microenvironment-based flexible factories or pre-assembled streamlined suite pods promoting closed processing within open-production halls or unclassified “ballroom” or “dance-floor” CNC suites. Such facilities might possess advanced in-line testing technologies, eventually establishing a global, enterprise process control integrating even the scheduling and management of such activities as raw material sourcing and equipment calibration.