DESIGN OF A NOVEL CONTINUOUS FLOW REACTOR FOR LOW PH VIRAL INACTIVATION

摘要

Currently the Biopharamaceutical industry is moving from operating in batch mode to continuous manufacturing. Low pH viral inactivation is a highly effective and a common method used in monoclonal antibody purification processes. During this unit operation the product is pooled and held, presenting a major bottle neck to end-to-end continuous downstream processing. Moving from a holding tank to a tubular reactor would provide for a means of processing materials continuously. The major challenges with tubular reactors for this application include limiting and characterizing the axial dispersion to ensure sufficient incubation time. The main objective of this work was to design and characterization of the residence time distribution (RTD), exit age of fluid elements leaving the reactor, of a continuous tubular reactor (CTR) for low pH viral inactivation.