13 ERA IB: ProSeCa - Recovery of high value Proteins from Serum by innovative direct Capture techniques

Many pharmaceutical drugs are made by extracting them from natural sources. However, many of these extraction methods are old-fashioned and inefficient. An example that we will be working on in this project is the extraction of veterinary drugs from equine (horse) serum. Current methods are complicated and cannot generate large yields of these veterinary drugs in a cost- and time-efficient manner. In addition, some current methods can damage the drug products, further lowering yields.

We aim to use magnetic technology to separate products from horse serum for use in veterinary medicine. We will develop methods to efficiently purify these products using a variety of approaches, all centred around the use of powerful magnets. The overall objective of the project is to develop these methods to a point where they can be applied commercially; this will be achieved by the design and development of procedures and equipment that can be implemented in a commercial setting. The overall objective is to decrease the overall time and cost of production of veterinary drugs; methods and techniques developed in the project may also be applied for the manufacture of human medicines, leading to benefits to the general public and medical profession.

The extraction of biopharmaceuticals from natural sources often employs overly complicated antiquated procedures. The downstream processing of serum is a case in point; it comprises large numbers of steps of low purification power and consequently delivers poor overall product yields.

Parallel advances in magnetic separation equipment and approaches to manufacture magnetic affinity particles, funded through several national and EU funded projects lay the foundations for the proposed work. Using magnetic bioseparation techniques, the consortium will seek to replace outdated organic solvent based fractionation methods, which can inflict serious damage on especially prone protein targets.

In ProSeCa, our combined expertise will be applied to the production of protein based veterinary medicines from horse sera, centring on harmonious integrated use of: highly selective magnetic adsorbents manufactured via: (i) chemical; (ii) biological; and (iii) mixed 'biological/chemical' routes; with a fully automated and cGMP compliant magnetic separator.

This project will specifically benefit researchers working within academia and businesses in the UK, the EU and worldwide. It will also generate impact for the general public through enhanced health and wellbeing, and the public sector through decreased drug costs.

The project will develop new methods to purify and process protein biopharmaceuticals. The objectives are process simplification and increases in process efficiency, leading to more rapid process development and more rapid protein purification. The focus in this project is equine medicine, but materials, equipment and methods developed in this project could also be applied (following the project) to other veterinary pharmaceuticals and human pharmaceuticals. This would benefit academics working in pharmaceutical development (drug design and discovery and manufacture) as well as the pharmaceutical and veterinary pharmaceutical industries. More effective processing tools for biopharmaceuticals could also enable biopharmaceutical drugs to get to market more rapidly and lower process costs, leading to improved economic competitiveness. Currently, the vast majority of protein biopharmaceutical production costs are derived from purification. The UK bioprocessing sector would potentially greatly benefit from outcomes of this project. The timescale for the translation of these project outcomes to industrial uptake is likely to be within 5-10 years of the project ending; integration of novel technologies into human biopharmaceutical production would take longer due to considerable regulatory pressure, although the technology could be more rapidly translated into other areas such as nutraceutical manufacture or veterinary medicine.

Faster time to market (thereby more rapid drug development pathways) and lower drug costs would benefit the general public, increasing health and wellbeing, by ensuring that new therapies would more rapidly be available and would be available to more people. Decreased drug costs would enable greater value for the NHS and thus UK government.

More fundamental technology that will be developed during the project (assay development; synthetic biology) will also generate impact. Synthetic biology of non-model organisms is an underrepresented area within synthetic biology, so this project will benefit academic and industrial researchers working in that area. This could potentially impact on biofuel and platform chemical production and bioremediation, to name three areas. Biofuels and biological platform chemical production both reduce reliance on fossil fuels and enable greater sustainability, with resultant environmental (lower emissions and waste) and economic benefits (rising costs of crude oil and energy, rising costs associated with waste discharge and carbon emission). Bioremediation also allows greater sustainability, land reuse and potential health benefits. These would have clear impacts for UK and EU business, government and the general public.