Factors affecting hollow fiber membrane virus filter performance due to protein fouling.
Open Access
Author:
Catrambone, Adam
Area of Honors:
Chemical Engineering
Degree:
Bachelor of Science
Document Type:
Thesis
Thesis Supervisors:
Andrew Zydney, Thesis Supervisor Dr. Michael John Janik, Thesis Honors Advisor
Keywords:
viral clearance IgG immunoglobulin G BSA bovine serum albumin hollow fiber membrane Planova BioEX Planova BioEX Planova 20N fouling antibody
Abstract:
Therapeutic antibodies are used for the treatment of a wide variety of cancers and autoimmune diseases. This has created a need for new and improved technologies to support the production and purification of these complex biological molecules. This includes methods for viral clearance, which is required to ensure that there are no exogenous or adventitious viruses in the final formulated product. The objective of this thesis was to examine the effects of factors such as protein concentration, transmembrane pressure, and solution pH on membrane fouling using Planova™ BioEX hollow fiber virus filtration membranes. Experiments were performed with solutions of human immunoglobulin G (IgG), with limited data obtained with the Planova™ 20N membranes and with solutions of bovine serum albumin (BSA). The fouling of the BioEX membrane decreased slightly at high pressures and high protein concentrations, but was relatively independent of the solution pH. BSA showed very little fouling of the Planova™ hollow fiber membranes over a range of conditions. These results provide important insights into the factors controlling fouling during virus filtration as well as a foundation for further optimization of the performance characteristics of the Planova™ BioEX membrane.