I-Corps Teams: Membrane Adsorbers for Biologics Purification

Clemson University, Clemson SC

Investigators

Abstract

Rising rates of chronic conditions such as cancer and cardiovascular diseases are driving the demand for biologic drugs used to treat them. Currently, there are over 130 biologics approved for use in the US, with a market exceeding $140 B. Over 900 new biologics targeting more than 100 diseases are under development. New product commercialization will require significant expansions in production capacity and improvements in manufacturing flexibility to meet future market demands. In addition, the emergence of biosimilars, biobetters, and increasing competition will apply economic pressure on biomanufacturers to innovate new drug manufacturing technologies to lower production costs. Innovations are especially needed in downstream drug purification, which often limits the production capacity and contributes 30-40% of the overall manufacturing cost. This I-Corps team is developing a platform (PuriTM membranes) to dramatically enhance production capacity and flexibility in the downstream purification of biologic drugs. The disposable nature of the PuriTM platform is expected to reduce biomanufacturing production costs significantly. This project is expected to accelerate market entry of PuriTM membrane innovations by developing the entrepreneurial knowledge and skills of the I-Corps team that are needed to translate the innovation from the academic laboratory to the industry sector. PuriTM adsorptive membrane modules are single-use membrane products that purify biologic drugs. They are characterized by high drug binding capacity, high selectivity, and high tolerance to feedstock conditions. Laboratory research has demonstrated that the firstgeneration PuriTM membranes specifically address all of the known customer pain points. Through customer interviews and use of the business model canvas, the team will test the proposition that these single-use adsorptive membrane innovations will derive commercial value from their abilities to increase the production capacity and flexibility of biomanufacturing facilities and lower the manufacturing cost of biologics. Identification of early acceptance customers also is expected as an outcome of the project. The team will develop alpha prototypes and work closely with potential customers on external validation of these prototypes. Completion of external validation will provide additional opportunities for the team to understand customer needs and test assumptions about the product utility and design. It also will provide vital data to attract external investors and new customers. A validated business plan and minimum viable products are expected at the end of the I-Corps program.