Contact: Ipshita Mandal, Matthew Townsend & Dr. Duncan Sharp, Department of Chemical Engineering & Biotechnology
Mentors: Wouter Meuleman & Dr. Marc Bax

The biopharmaceutical industry is growing rapidly, currently standing at a market capitalisation of over $140bn, and growing at 15-18% per year. With the increase in demand for biopharmaceuticals, there are key process limitations in biomanufacturing. Optimised production in bioreactors has led to high yields (>10g/L of antibody-producing cells for example). However, this has increased demand for high capacity and throughput in the downstream purification processes. Currently the downstream processes account for 50-60% of the total production costs of such molecules. Major limitations in current technologies include fouling, high cost and slow processing times to achieve the required separation resolutions.

Researchers at the Department of Chemical Engineering & Biotechnology have developed and patented a novel Micro-Capillary Film (MCF) manufactured from polymer materials, and are now investigating its application in different areas of purification of biologicals – spanning biopharmaceutical drugs (antibodies and proteins) and cell populations. The new matrix material provides regular microporous micro-capillaries, whose size can be varied at time of manufacture. The porous nature of the surface gives approximately 10,000 times higher protein binding when compared to non-porous matrices (*)

Compared to the current commercial systems used for protein separation, the new technology is comparable in capacity, with the added advantages of being lower cost, and able to operate at higher flow rates and pressures whilst maintaining separation resolution. The differences may enable not just improvements to existing systems, but may allow an entirely new approach to some applications, such as the development of single-use disposable cell separators for use in cell therapies, and systems that can be used easily without the need for specialist operators.

The i-Team’s goal is to investigate the wide range of possible applications for this new platform technology, discovering the market needs for each application and any barriers to entry in those markets that would hinder adoption of the new approach (for example changing the purification processes for pharmaceutical products requires additional FDA approval). The inventors are interested both in short-term markets that could benefit from the technology straight away, and longer-term markets that may create entirely new ways of producing biotech applications of the future.

(*) The non-porous micro-capillary matrices were the subject of an earlier i-Teams project Barcode biosensors in Easter 2010