Early phase process development toolkit (InsidePharmasystems)

点击翻译按钮获取中文摘要

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.