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

该方案旨在建立生产重组蛋白质，特别是生物制药和定制动物疫苗的最先进设施和技术。生物制药是用于治疗越来越广泛的严重疾病的蛋白质药物，预计到2020年，所有新药中有一半将是生物制药。它们通常是在细菌或动物细胞中产生的，这使得它们很难制造，而且对于发展中国家的绝大多数患者来说过于昂贵。在泰国，只有不到2%的患者能够获得在英国常规使用的抗癌生物药物，这些药物被列入世界卫生组织的“基本医疗保健系统最低药物需求”清单。泰国的癌症发病率很高，而且还在上升，因此对这些药物的需求很大。需要动物疫苗来对抗牲畜感染，由于人口增长的需求增加，这在泰国和其他国家是一个日益严重的问题。许多进口疫苗效果不佳，因为它们是针对差异太大的菌株培养的。泰国和其他发展中国家每年都遭受牲畜的巨大损失，一些疫情导致90%的损失率。泰国等国家只能通过自己生产成本低得多的生物制药和配制与流行病毒株相匹配的疫苗来解决这些问题。这两个领域的进展需要大规模的重组蛋白生产设施，通常在大肠杆菌中。大肠杆菌或哺乳动物细胞。这是一个非常复杂的领域，大多数发展中国家没有这种能力，因此需要进口产品。为了解决这个问题，泰国政府于2014年建立了一个专门建造的国家生物制药设施（NBF），该设施配备了细菌/动物细胞系统和产品配方。它还建立了一个庞大的动物疫苗研究小组。英国在“生物加工”领域拥有世界一流的专业知识，该项目旨在应用这些专业知识，首先在泰国，然后在其他地方，将NBF发展成为一个可以生产生物制药和疫苗抗原的最先进的设施。英国团队包括生产链每个步骤的专家，包括表达系统的设计，高水平蛋白质的表达，大规模培养，产品提取/纯化和产品“分析”。后一个领域至关重要;任何获得许可用于人类的药物都必须通过极其严格的质量测试，包括对最终蛋白质产品的详细分析。在项目期间，一组英国申请人将与泰国团队密切合作，将他们的能力转移到泰国中心，并建立生产能力。这将通过长期借调英国研究人员到泰国以及泰国研究人员访问英国学习新方法来帮助。与此同时，英国和泰国的其他团队成员将与政府部门、公司和农场合作，确保产品有效分销，以便到达最终用户手中。最后，来自一系列东南亚邻国的代表将参加网络会议，以便他们充分了解该方案的进展和产出，并能够利用信息和技术启动自己的生产管道。

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.