Early phase process development toolkit (InsidePharmasystems)

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.

This proposal is focused on the market opportunities provided by the fine chemicals and pharmaceutical industries, where industry needs are well-defined and there is an established route to market through BRITEST. The Early Phase Process Development Toolkit (InsidePharmasystems - TM) will help realise both whole process design and improved risk analysis, resulting in the development of the 'optimal' manufacturing process to meet the business requirements. A survey of the Britest members identified that risk analysis was rarely carried out, if at all, during early route and process selection and what risk analysis was carried out was often very experimental and based on recent projects. This Toolkit will enable companies to carry out a structured rational risk analysis allowing them to make informed decisions that incorporate company business drivers. Just considering the Britest membership, the inclusion of a fully developed Early Phase Development Toolkit in the Britest toolkit would allow companies to select the optimal manufacturing process earlier. This can confidently be anticipated to deliver savings in excess of 2million per year per industrial user. Looking beyond the Britest membership, there are approximately 1000 chemical manufacturing companies conducting process development in the UK. Extrapolating, if all companies were to use this Toolkit, then savings of 2000 million could be anticipated. Additionally there is significant potential for the product outputs to ultimately be diversified into a range of related knowledge management toolkits tailored to other emerging industry sectors of strategic importance to the future knowledge-based UK economy. Two industry sectors of particular relevance in this respect are renewable chemicals and regenerative medicine. Both of these sectors are the subject of significant government investment and both have a strong requirement for early-stage knowledge management of complex bioprocesses. Moreover the Biopharmaceutical and Bioprocessing Technology Centre (BBTC) is already strongly engaged with the effort to accelerate the emergence of these UK sectors. It is envisaged that a far greater economic impact in the longer term will materialise by designing new, but related, knowledge management toolkits that are tailored for the specific technical and business requirements of these emerging industry sectors. The fundamental and universally applicable capability of the emergent products, relevant to all sectors, is the ability to guide the non-expert user through the technical and business risk-based decision-making process. The parameters guiding the user will be unique to individual sectors (e.g. technical, business and regulatory differences) and these aspects will be incorporated in product development, through future work, by partnering with companies or consortia (aided by existing relationships with KTNs and similar networking organisations such as Rengener8) in a business model that mirrors our current product development and route-to-market partnership with BRITEST. In summary, by expanding the product range to encompass emerging strategic industry sectors of renewable chemicals and regenerative medicine, the BBTC will play an important role in accelerating economic, social and health benefits.