Date of Graduation

8-2017

Document Type

Thesis

Degree Name

Master of Science in Biomedical Engineering (MSBME)

Degree Level

Graduate

Department

Biomedical Engineering

Advisor/Mentor

Qian, Xianghong

Committee Member

Wickramasinghe, S. Ranil

Second Committee Member

Muldoon, Timothy J.

Keywords

Bacteriophage; Downstream process; Virus filtration

Abstract

Virus Clearance is one of the major challenges in biopharmaceutical industry, especially in the manufacturing of drugs. U.S. Food and Drug Administration (FDA) recommends using several model bacteriophages as surrogates of pathogenic mammalian virus for process validation. In this work, two bacteriophages were tested against 30 kDa, 100 kDa, 300 kDa polyethersulfone (PES) membranes to investigate the effects of pore size on virus clearance. Virus particles were spiked into the protein feed solutions containing bovine serum albumin (BSA) or lysozyme at different concentrations. Besides protein concentration, the effects of feed pH on the filtration performance and virus rejection were also investigated.The results indicate that 100 kDa PES membrane can remove 4 logs of virus from the feed stream with and without protein while maintaining a moderate flux performance. pH does not appear to significantly affect the virus rejection. However, flux is somewhat higher when the pH of the feed is close to neutral. These results indicate that electrostatic interaction between the protein, virus particle and the membrane has a strong effect on flux and virus rejection.

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