Biomedical Engineering and Bioengineering Commons^™

Effects Of Filtration Conditions On Clearance Of Bacteriophage, Rigen Te

Graduate Theses and Dissertations

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 …