An assessment is proposed of continuous, high-g centrifugation for production purification of medical proteins. Proteins are separated today in ultra-centrifuges, but it is not continuous and the method has not been all scaled up. The specific objectives are to assess separation selectivity and throughput rate; and possible biological damage to the protein by shear, by sedimentation, and by intense centrifugal force. The focus of the analysis will be on internal flows in the rotating fluid and their impact on sedimentation and separation selectivity. The focus of the experiments will be on the protein. Research on the hardware is reserved for Phase 11. No hardware features are believed to be beyond the state-of-the-art. An exploratory design will be made for cost comparison to chromatography. If continuous centrifugal purification is feasible, a new method of downstream processing becomes available to the biotechnology industry. Because downstream processing now represents 70-806Sc of the product cost, centrifugal separation could lower significantly the cost to the patient of new drugs.Anticipated Results and
Potential Commercial Applications: This research could generate the scientific basis needed to engineer new purification equipment for production of medical proteins expressed from cell culture.
