This SBIR Phase II project will address the need for column chromatography products that can simplify the purification process for therapeutic biologics and increase purification speed. The rapid pace of biologics development, driven in part by growth of emerging markets such as personalized medicine, has increased the demand for affordable and fast, small-batch production runs in multi-product biopharmaceutical facilities. Disposable technologies like the one proposed that can rapidly and efficiently purify biologics will contribute to improving human health by enabling the small-batch production of affordable medications. The products of this SBIR Phase II project will be single-use, multimodal anion-exchange membrane (MMAEX) chromatography columns that have a high capacity for removing impurities such as host cell proteins, DNA and aggregates from biologic products under conditions of high solution conductivity. Current products have low capacities, and the efficiency of impurity removal is heavily compromised at elevated solution conductivities. By overcoming these limitations, Purilogics' products will enable rapid purification without buffer exchange or adding additional chromatography steps, thus saving time and simplifying the purification process. In Phase I, we proved the feasibility of fabricating high capacity MMAEX membrane columns. Product prototypes outperformed the best competing products, and performance metrics exceeded the defined acceptance criteria for moving to Phase II. A partner biopharmaceutical company used the prototypes to purify cancer antibodies 10 times faster than their current practice and attained the same purity level.
The aims of the Phase II study are (i) to develop MMAEX membranes with increased capacity, reduced purification time, and enhanced impurity removal capability; (ii) to finalize a production process for sterile membrane columns with defined product shelf life, and (iii) to delineate operating ranges and conduct field research on membrane column prototypes.
In Specific Aim 1, systematic studies will be carried out to determine the roles played by synthesis conditions and membrane properties on performance.
In Specific Aim 2, a semi-continuous process will be established to produce prototypes for determining sterilization protocols and product shelf life. A scale-down spiral-wound membrane column will be designed and fabricated to collect data for predicting performance at large scale.
In Specific Aim 3, Purilogics will collaborate with researchers at Clemson University and University of Arkansas to identify the MMAEX column operating design space and to determine viral clearance. Field research will be done at the facilities of three industry partners to develop novel purification schemes for different types of biologics. The new column will be compared against commercial products. Market entry will be through sales to scientists and engineers in biologics research and development laboratories through established channels. The addressable market for single-use polishing step purification columns <1 L is expected to reach $271 million by 2020.
In this Phase II SBIR project, Purilogics, LLC will develop single-use membrane chromatography products that simplify the purification process for biologics and increase the purification speed. Biologics are in high demand to treat chronic conditions including a number of cancers, autoimmune disorders, cardiovascular diseases, and many orphan diseases. Purilogics' membrane products will contribute to improving human health by enabling the rapid production of affordable medications.