GCRF establishment of biopharmaceutical and animal vaccine production capacity in Thailand and neighbouring South East Asian countries

This programme aims to establish state of the art facilities and technology for the production of recombinant proteins, especially biopharmaceuticals and bespoke animal vaccines. Biopharmaceuticals are protein drugs that are used to treat an increasingly wide range of serious diseases, to the extent that half of all new drugs are predicted to be biopharmaceuticals by 2020. They are usually produced in bacterial or animal cells, which makes them difficult to make and far too expensive for the vast majority of patients in developing countries. In Thailand, fewer than 2% of patients have access to anti-cancer biopharmaceuticals that are routinely used in the UK, and which are on the World Health Organisation's list of 'minimum medicine needs for a basic health-care system'. Cancer rates in Thailand are high and rising, so there is a profound need for these medicines. Animal vaccines are required to combat infections in livestock, which is a growing problem in Thailand and other countries due to the increasing demands of growing populations. Many imported vaccines do not work well because they were raised against strains that are simply too different. Thailand and other developing countries suffer massive losses in livestock every year, with some outbreaks leading to 90% loss rates. Countries such as Thailand can only address these problems by producing the biopharmaceuticals themselves, at much lower costs, and by formulating vaccines that are matched to circulating viral strains. Progress in both areas requires large scale facilities for recombinant protein production, usually in E. coli or mammalian cells. This is a highly complex area and most developing countries do not have this capacity - hence they need to import the products. To address this problem the Thai government has established a purpose-built National Biopharmaceutical Facility (NBF), built in 2014 and fully equipped for bacterial/ animal cell systems and product formulation. It has also developed a substantial animal vaccine research group. The UK has world-class expertise in this area of 'bioprocessing' and this project aims to apply this expertise, initially in Thailand and later elsewhere, to develop the NBF into a state of the art facility that can make both biopharmaceuticals and vaccine antigens. The UK team includes experts in every step of the production chain, including design of expression system, expression of proteins at high levels, large scale cultivation, product extraction / purification, and product 'analysis'. The latter area is crucially important; any drugs licensed for human use have to pass extremely stringent quality tests that involve detailed analysis of the final protein product. During the project a group of the UK applicants will work closely with the Thai team to transfer their capabilities to the Thai centres and build up production capacity. This will be aided by seconding the UK researchers to Thailand for long periods, and visits by the Thai researchers to the UK to learn new approaches. At the same time, others UK and Thai team members will work with government ministries, companies and farms to ensure that the products will be distributed effectively so that they reach end users. Finally, representatives from a range of neighbouring South East Asian countries will be involved in the network meetings so that they are fully aware of the programme's progress and outputs and able to use the information and technology to initiate their own production pipelines.