Early phase process development toolkit (InsidePharmasystems)

本提案的总体目标是采用EPSRC项目SatNav（EP/F016913/1）资助的原理验证研究中开发的工具，并通过开发早期工艺开发工具包（InsidePharmasystems-TM）将其转化为商业机会。该工具包将实现精细化学品和制药行业从开发到制造战略的根本性变革。该工具包的基础是一个知识框架，该框架将使工业界能够在更加知情的基础上选择最适当的化学路线和工艺设备，同时考虑到商业驱动因素、产品开发和扩大制造规模的挑战之间的相互作用。该项目的产出将使英国企业有机会在化学路线选择方面的反应能力和经济竞争力方面领先国际领域，从而实现新的商业机会。2007年，EPSRC支持的“沙坑”项目获得了一个可行性项目的奖励。（EP/F016913/1）旨在开发一种方法，该方法能够指导那些参与工业精细化学品/制药化学品工艺开发的人，帮助他们在路线选择方面做出更有效的决策。路线选择仍然是一个真实的工业问题，因为它是耗时的，浪费了大量的精力和资源。此外，由于流程操作要求在满足法规、环境和经济要求方面变得更加严格，因此决策过程变得“更难”，并且集成业务驱动因素以进行明智决策的需求甚至更大。该项目的工业合作伙伴提供了建立当前“最佳”做法的关键信息。这证实了广泛接受的观点，即制药/精细化学品行业的当前方法通常是划分的，总体业务目标是远程考虑因素，甚至生产规模工程限制对于参与早期工艺开发和负责路线选择决策的人员来说也不是最重要的考虑因素。在提供解决办法方面取得了重大进展。在本提案中开发的产品将扩展和利用SatNav中开发和演示的工具，并使参与早期开发的化学家和化学工程师能够通过实施早期工艺开发工具包（InsidePharmasystem - TM）做出更及时，适当和明智的决策，并考虑到业务驱动因素。后续基金的申请将促进进一步的科学和技术发展，以便将现有的概念从原则证明一直推广到证明工具包的商业可行性。通过工业部门专家的持续参与，该项目将确保通过若干工业试验台应用，从根本上提高市场认识，并使产品符合需要。

The overarching aim of this proposal is to take the tools developed within a proof-of-principle study funded through the EPSRC project SatNav (EP/F016913/1) and translate them into a business opportunity through the development of an Early Phase Process Development Toolkit (InsidePharmasystems -TM). The toolkit will realise a fundamental change in the development-to-manufacture strategy within the fine chemicals and pharmaceutical manufacturing sectors. The basis of the Toolkit is a knowledge framework that will enable industry to select, on a more informed basis, the most appropriate chemical route and process equipment, that takes into consideration the interplay between the business drivers, product development and the challenges of scale-up to manufacturing. The output from the project will provide the capability to move UK business to a position where they have the opportunity to lead the international field in terms of responsiveness and economic competitiveness with regard to chemical route selection and hence realise new business opportunities.In 2007 an EPSRC supported 'sandpit' resulted in the award of a feasibility project (EP/F016913/1) aimed at developing a methodology that has the ability to guide those involved in industrial fine chemical / pharmaceutical chemical process development in a way that could assist them in making more effective decisions in terms of route selection. Route selection remains a real industrial issue in that it is time consuming with significant effort and resources wasted. Furthermore as process operating requirements become tighter in terms of satisfying regulatory, environmental and economic requirements, so the decision making process becomes 'harder' and the need to integrate business drivers for informed decision making even greater. The industrial partners in the project provided critical information in terms of establishing current 'best' practice. This confirmed the widely accepted belief that the current approach in the pharmaceutical/ fine chemicals industry sector is typically compartmentalised, with the overall business objectives being remote considerations and even production scale engineering constraints not being paramount considerations for those involved in early stage process development and responsible for making decisions on route selection.Within the EPSRC SatNav project, significant advances were made towards providing a solution. The product to be developed within this proposal will extend and exploit the tools developed and demonstrated within SatNav and will enable chemists and chemical engineers involved in early stage development to make more timely, appropriate and informed decisions that take into consideration the business drivers through the implementation of the Early Phase Process Development Toolkit (InsidePharmasystem - TM). This Follow on Fund application will facilitate the further scientific and technical developments necessary to take the existing concepts from proof of principle through to demonstrating commercial viability of the Toolkit. Through the continued involvement of industrial sector specialists, this project will ensure that market awareness and product tailoring to need are inherently addressed through a number of industrial test-bed applications.