SBIR-STTR Award

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.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project addresses the high costs of manufacturing protein therapeutics, or biologics. Biologics are a growing category of therapeutic that can treat a range of diseases from rheumatoid arthritis to ulcerative colitis to Alzheimer's. Unfortunately, producing these highly effective therapeutics is extremely expensive, with most of the cost stemming from the purification of the target protein from a complex mixture. This Phase II project aims to develop a new filter device that makes purifying biologics faster and cheaper. The filter media will increase overall throughput, thereby easing bottleneck steps in the purification process. In addition to decreased manufacturing costs, the expedited purification also increases the overall capacity of the manufacturing line. This high throughput filter device is designed to fit seamlessly into existing purification modules, making it easy for end users to increase production efficiencies.This SBIR Phase II project aims to dramatically improve the performance of ultrafiltration membranes used in protein separations. Currently existing ultrafiltration membranes suffer from either prohibitively low throughputs or broad pore sizes, limiting their efficacy in separation processes. This project takes advantage of a unique class of polymeric materials, known as block copolymers, to make membranes that overcome the previous structural limitations. Namely, the block copolymer membranes have very high throughputs and very uniform pore sizes. These important features are possible due to the distinct ability of block copolymers to self-assembly into periodic, ordered structures with length scales relevant for protein separations. Using a combination of block copolymer self-assembly and non-solvent induced phase separation, membranes with targeted pore sizes can be made in scalable way. The research objectives for this project are to increase the porosity of the supporting block copolymer material, attach the block copolymer membrane to a fabric backing, evaluate the performance of assembled membrane sheet stock, and package the sheet stock into a device configuration. Accomplishing these research objectives will result in a mechanically robust, easy to implement membrane material that can increase the rate of protein filtration by 3-10 fold.