This Small Business Innovation Research Phase I project addresses separation needs of biopharmaceutical manufacturers by developing novel membranes with exceptional performance. Currently available membranes used to separate therapeutic proteins suffer from broad pore size variations, resulting in additional expensive processing steps to the separations. TeraPore's patented membrane technology enables the production of high throughput membranes with uniform pores with sizes targeted to proteins used in medicine, resulting in cheaper, more efficient separations. Customer needs in this industry are dependent on the specific molecules being separated, requiring a suite of membranes with tunable and reproducible pore sizes. This feasibility study will show that changing the molecular structure of the polymers used to make the membranes can control this pore size effectively. The outcome of this research will allow TeraPore to make a variety of membrane products and specifically design polymers that results in membranes that address specific customer needs.
The broader impact/commercial potential of this project includes the production of high margin membrane products that will significantly improve efficiency in the processing of therapeutic biomolecules. The US market for membrane technology in biopharmaceutical processing was $2.4B in 2011 and is growing at a rate of over 10%. Given the performance advances possible with TeraPore's membranes, the company intends to enter the marketplace through the biopharmaceutical processing market through separation/purification applications involving high value, high margin biopharma products processed by TeraPore's membranes.
TeraPore has developed a new type of filter technology for purifying biomolecules such as globular proteins. In this Phase I SBIR project, TeraPore established the feasibility of this new technology by exploring how tailoring the physical properties of the starting polymers used to make the filters can lead to filters with different pore sizes. Because proteins come in all shapes and sizes, it is important that filter users have multiple options with respect to filter performance. Over the past decade, therapeutic drugs are increasingly made in cells as opposed to being synthesized in the lab. These new drugs, referred to as biologics, are often proteins with much more complicated structures and behaviors than their small molecule predecessors. While these new biologics can be particularly effective for treating diseases ranging from cancer to alzheimers to rheumatoid arthritis, their increased complexity results in very high manufacturing and purchase costs. In particular, separating out the specific biologic of interest from cell mixtures containing hundreds if not thousands of other components, is very difficult. TeraPore’s new high performance filters have the potential to make this separation much easier, offering the potential to increase access to these important therapeutics. TeraPore’s filters are made using a unique type of polymer, called a triblock terpolymer, with three distinct chemical components. In the right mix of organic solvents and under the appropriate processing conditions, these terpolymers self-assemble into membranes that have very uniform pores and high pore densities. In contrast to the membranes used to purify proteins today, TeraPore’s membranes can distinguish between similarly sized proteins due to their uniform pores. In this Phase I NSF SBIR project, TeraPore worked in collaboration with researchers at Cornell University to synthesize small, medium, and large terpolymers to use as starting materials for making filters. The special terpolymers were characterized in bulk as well as in solutions of organic solvents to better understand how the terpolymer behaves under a variety of conditions. With this information in hand, the terpolymers were then used to make filters. Finally, the filters were tested with pure water and with solutions containing various proteins to understand how they perform. Five different terpolymers were ultimately synthesized for use in this study. Except for the largest terpolymers, all starting materials self-assembled in the same way in the bulk, while all the terpolymers self-assembled in the same way in solution. When processed in the appropriate way, the smaller terpolymers resulted in filters with smaller pores and the larger terpolymers resulted in filters with larger pores, demonstrating that the critical ability to tune pore size is possible with TeraPore’s technology. The size of the pores was tested by passing solutes, suh as coiled polymers and proteins, through the membranes and examining how much got through. The amount of solute that passed through the membranes confirmed the different pore sizes between filters made from each terpolymer.
