Document Type

Working Paper

Date of this Version

4-2011

Abstract

Ultrafiltration (UF) membranes are required in the biopharmaceutical industry to concentrate or purify the final biologic product, thereby ensuring patient safety and fulfilling regulatory requirements. It is crucial that biotechnology clients select the optimal operating parameters for each filtration step. Unsuccessful filtrations might fail to purify a near-finished drug product, thereby wasting product and incurring financial loss. In less extreme cases, failure to optimize filtration steps will lead to slowed filtration steps, potentially causing bottlenecks and reduced throughput. Overall, efficient, effective filtration is crucial to the financial success of biopharmaceutical companies.

Generally, these companies pre-test filtration processes using commercially available filter test rigs. Although commonly used, these filters are geometrically and mechanically simplistic and therefore provide an incomplete picture of filter behavior. Results from these simple filters do not appropriately represent the behavior of complex industrial filters. As a consequence, filtration tests are inherently flawed and industrial processes are not optimized.

OptiFilt will solve this problem by providing more accurate filtration analysis services to biotechnology client companies. Using proprietary computational models and experimental analysis, OptiFilt will determine unknown hindered convective and diffusive coefficients of client-supplied test UF material. OptiFilt scientists will determine the unknown properties by fitting the parameters to a MATLAB model for dead-end flow with fouling. The results from this MATLAB model will be supplied to a tangential flow filtration COMSOL model which more appropriately describes industrial filter behavior. Overall, this process will provide more accurate predictions of filter behavior, thereby allowing our clients to more effectively optimize their filter operating parameters.

We project that OptiFilt filtration analysis services will help our clients reduce filtration time and increase throughput by 50%. As a result, clients will enjoy increased profitability. OptiFilt, then, will provide biotechnology clients with a crucial advantage in these competitive times.

OptiFilt will function as a start-up company, beginning its R&D stage in 2012 and seeking investments in 2012 and 2013. Financial analyses have confirmed that this is a profitable and relatively secure venture, even in the case of events which could adversely affect the business.

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Date Posted: 24 July 2012