EPSRC Centre for Doctoral Training in Emergent Macromolecular Therapies (EMT): A National CDT linked to an EPSRC Centre for Innovative Manufacturing

生物加工工业生产新的大分子药物，蛋白质，以解决广泛的慢性和衰弱的人类疾病。这些基于蛋白质的药物的复杂性使它们在对抗疾病方面具有巨大的潜力，但它们也比传统的化学药物更不稳定，制造起来也更具挑战性。随着新技术的出现和新疗法的出现，这一挑战正在迅速增加，例如与化学药物实体、DNA、RNA或脂质结合的蛋白质，或多种蛋白质的融合，这增加了它们的效力和对患者的靶向递送。英国凭借其科学基础和独特的大学能力，在开发和制造新疗法方面处于领先地位。虽然收入很大，2009年全球范围内约为1100亿英镑，但如果要满足医疗保健成本降低和废物最小化的要求，并且要使人们从可用的最有效药物中受益，该行业面临着巨大的变革压力。如果要让现代药物的潜力得到广泛应用，那么在未来十年，制造业将需要发生翻天覆地的变化。此外，人们普遍认为，缺乏具有基本“蓝天”思维能力的人才，同时也缺乏该行业所需的制造研究培训。拟议中的EPSRC CDT将为英国生物制药部门培养下一代高技能的未来领导者和生物工艺制造研究人员提供国家能力。他们将能够将制造技术和新型大分子产品的新科学进展转化为安全生产、更具选择性的治疗方法，以负担得起的成本治疗当前棘手的疾病。这被认为是至关重要的，因为生物制药的快速发展及其制造将对未来的医学产生重大影响。CDT将成为EPSRC新兴大分子疗法创新制造（CIM）中心（EP/I033270/1）的国家资源，该中心旨在解决基于全新化学和分子生物学的复杂疗法制造过程中出现的新工艺工程、产品稳定性和产品分析挑战。CDT将把博士生嵌入到英国顶尖机构充满活力的研究社区，由EPSRC CIM监督合作，使探索新的工艺工程，建模，分析，配方和药物输送技术，以及新的疗法（例如融合蛋白，结合抗体的化学药物），因为它们来自国际科学和工程界。与EPSRC CIM保持一致将确保项目战略性地解决工业用户群体确定的关键生物工艺制造挑战，同时提供基于队列的培训环境，利用ESPRC CIM的卓越研究成果，最大限度地提高合作伙伴向研究主导公司的影响和知识转移。

The bioprocess industry manufactures novel macromolecular drugs, proteins, to address a broad range of chronic and debilitating human diseases. The complexity of these protein-based drugs brings them significant potential in terms of potency against disease, but they are also much more labile and challenging to manufacture than traditional chemical drugs. This challenge is continuing to increase rapidly as novel technologies emerge and make their way into new therapies, such as proteins conjugated to chemical drug entities, DNA, RNA or lipids, or fusions of multiple proteins, which increase their potency and targeted delivery in patients. The UK holds a leading position in developing and manufacturing new therapies by virtue of its science base and has unique university capabilities underpinning the sector. Whilst revenues are large, ~£110bn in 2009 on a worldwide basis, there are huge pressures on the industry for change if demands for healthcare cost reduction and waste minimisation are to be met, and populations are to benefit from the most potent drugs becoming available. A sea change in manufacturing will be needed over the next decade if the potential of modern drugs are to make their way through to widespread distribution. Moreover there is a widely accepted skills shortage of individuals with fundamental "blue-skies" thinking capability, yet also with the manufacturing research training needed for the sector. The proposed EPSRC CDT will deliver a national capability for training the next generation of highly skilled future leaders and bioprocess manufacturing researchers for the UK biopharmaceutical sector. They will be capable of translating new scientific advances both in manufacturing technologies and new classes of macromolecular products into safely produced, more selective, therapies for currently intractable conditions at affordable costs. This is seen as essential where the rapid evolution of biopharmaceuticals and their manufacturing will have major implications for future medicine. The CDT will be a national resource linked to the EPSRC Centre for Innovative Manufacturing (CIM) in Emergent Macromolecular Therapies (EP/I033270/1), which aims to tackle new process engineering, product stability, and product analysis challenges that arise when manufacturing complex therapies based on radically new chemistry and molecular biology. The CDT will embed PhD students into the vibrant research community of the top UK Institutions, with collaborations overseen by the EPSRC CIM, to enable exploration of new process engineering, modelling, analysis, formulation and drug delivery techniques, and novel therapies (e.g. fusion proteins, and chemical drugs conjugated to antibodies), as they emerge from the international science and engineering community. Alignment to the EPSRC CIM will ensure projects strategically address key bioprocess manufacturing challenges identified by the industrial user group, while providing a cohort-based training environment that draws on the research excellence of the ESPRC CIM to maximise impact and knowledge transfer from collaborative partners to research led companies.