13TSB_TIBio: Technology Inspired Innovation Bioscience - Puridify

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This collaborative project between our leading academic group at UCL and SME Puridify gives the opportunity for a highly focused project with high level expertise to carry out the technologically innovative work described below aiming to address the established purification challenges during industrial manufacture of biopharmaceuticals. UCL and Puridify are supported in this activity by three industrial partners selected to provide support to the analytical and manufacturing aspects (being leading companies in their respective areas) as well as to provide a route to transfer the findings of the research to practice. The research collaboration described here is focused on the study of the performance of the core purification method used for the manufacture of biopharmaceuticals - chromatography. Specifically we seek understand the methods of immobilisation for this novel matrix material thereby allowing for optimised fabrication of functional adsorbent materials. This is an essential part of establishing a robust purification platform with a novel technology that offers significant operations advantages in terms of productivity, lifetime, feedstream complexity and indeed opportunity to facilitate continuous downstream operations. Biopharmaceuticals are an increasingly important sector of the pharmaceutical industry, over one third of all drugs now in development are biopharmaceuticals and they make up half of the top 10 revenue blockbusters. It takes over 10 years and $800 million to develop a new drug. The attrition rate for biopharmaceuticals is severe, only 9% at Phase 1 clinical trials reach the market and only 3 out of 10 drugs launched actually generate enough revenues to recoup development costs. Given the high attrition rate during development, companies are resistant to committing manufacturing resources at the early stages. The potentially significant manufacturing cost reduction that this technology is capable of reduces this early burden with significant external 'spill over' benefits. The new bioprocess purification technologies created here would continue to allow UCL to play their part in advancing manufacturing routes to the UK bioindustry while maintaining research at the forefront of industrial development. The UK bioprocessing sector is economically important, currently over 480 companies, employing 26,000 people and generating annual revenues of £4bn. The deliverables of this CRD project are a key step towards developing this technology for industrial implementation. The industry has to reduce costs to make biotherapeutics more widely available and to increase the amount of research in the area. Key objectives relating to UCL's involvement in this CRD project are listed below: - Expand knowledge and research activity in the area of purification within the department and UCL. - Disseminate this work by publishing papers with the aim of generating further research opportunities and increased collaborations. - Contribute to industrially focused developments of a new technologies and screening platforms. - Share knowledge through events such as MBI training courses, conferences and teaching. - Introduce new analytical techniques and develop leading technologies.