A high-efficiency, low-cost, single-use purification technology for therapeutic antibody manufacturing

Therapeutic antibodies have had a profound impact on treatment of many types of cancer and autoimmune diseases with many new therapeutics in development. However, antibodies are extremely expensive to produce, and large amounts of antibody are required to achieve clinical efficacy. In our 268 interviews with industry experts and extensive research of the literature, Protein A-based purification is the largest pain point in mAb manufacturing. The Protein A market was $600 million in 2019 and is projected to grow to over $1 billion by 2026. This market can be divided into the classical resins that have dominated the market and new alternatives which include membranes. There is a strong desire to move away from resins; however, a lack of alternatives with superior performance have prevented this. Our Phase I data demonstrate that we have considerable advantages over incumbent suppliers by providing a high binding capacity, high-flow, single-use membrane that doesn’t rely on crosslinking. At the end of Phase II, we will produce our minimally viable product: a low-cost, high-capacity, single-use antibody purification membrane that has been validated by key industry players and ready to be displayed internationally. To do this we will accomplish the following Aims: 1) Industrial Scale Production of protein monomers 2) Optimize efficiency of electrospun membrane 3) Testing with Industry Partners. The slow adoption rate of new technologies, preference for brand reputation, compliance with FDA SOPs, global supply risk, and long runway to revenue lead to start-ups similar to ours being acquired before any sales occur. Therefore, our goal is not to manufacture and sell this product but to pursue an early exit through licensing, partnership with, or acquisition by, established companies. To accomplish this, we will leverage the data generated from industry partners during this Phase II proposal to generate high profile scientific publications and presentations at leading conferences.