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The use of disposable technologies in biopharmaceutical purification processes

Presented at: 2012 American Association of Pharmaceutical Scientists Annual Meeting and Exposition; 2012 Oct 14-18; Chicago, IL.

With the rapid advance of single-use bioreactors and other technologies enabling large-scale production of biopharmaceuticals using disposables, the demand for disposable-format downstream process technologies is increasing. While single-use capsule filters have been used in biomanufacturing for decades, other downstream unit operations, such as chromatography and tangential flow filtration have only recently been accessible at production scale with single-use equipment. New technologies, such as single-pass ultrafiltration and BioSMB, promise to expand the use of disposable technologies in biopharmaceutical purification processes. This presentation will provide a review of the driving forces for adoption of disposables as well as an overview of recent advances specifically applicable to the purification and downstream processing sections of the biopharmaceutical flowpath.