
Novasep SAS
Novasep SAS
1 Projects, page 1 of 1
assignment_turned_in Project2007 - 2012Partners:Eli Lilly (United States), Merck & Co Inc, Avecia Limited, Novo Nordisk A/S, Intercell Biomedical Ltd +60 partnersEli Lilly (United States),Merck & Co Inc,Avecia Limited,Novo Nordisk A/S,Intercell Biomedical Ltd,Lonza (United Kingdom),UCL,BioPharm (United Kingdom),AstraZeneca (United Kingdom),Eli Lilly (United Kingdom),Bio Products Laboratory (United Kingdom),DHSC,GlaxoSmithKline,BIA Seperations,MEDISIEVE,Amgen (United Kingdom),Pfizer Global R and D,GE HEALTHCARE LIMITED,SGUL,Novo Nordisk (Denmark),Biovex Ltd,UCB UK,Protherics UK Limted,National Institute for Biological Standards and Control,Intercell Biomedical Ltd,GE (General Electric Company) UK,GlaxoSmithKline R&D Ltd,Eli Lilly (United States),TAP Biosystems,Prometic Biosciences Ltd,Merck and Co Inc,Pfizer (United Kingdom),PHE,UCB Pharma (United Kingdom),Avecia (United Kingdom),Public Health England,General Electric (United Kingdom),UCB Celltech (UCB Pharma S.A.) UK,BIA Seperations,PEL,General Electric (Sweden),GlaxoSmithKline PLC,Pfizer (United States),Novasep SAS,GlaxoSmithKIine,Pfizer,Pfizer Global R & D,PUBLIC HEALTH ENGLAND,General Electric Company,Wyeth USA,Sartorius (United Kingdom),Eli Lilly and Company Limited,Pall Corporation (United Kingdom),BTG International (United Kingdom),Protherics UK Limted,LONZA BIOLOGICS PLC,Liminal BioSciences (United Kingdom),Novasep SAS,Nat Inst for Bio Standards and Control,Wyeth USA,BPL,BioPharm Services Ltd,Protherics Plc,MSD (United States),Pfizer Global R and DFunder: UK Research and Innovation Project Code: EP/E001599/1Funder Contribution: 5,913,160 GBPIt is now widely accepted that up to ten years are needed to take a drug from discovery to availability for general healthcare treatment. This means that only a limited time is available where a company is able to recover its very high investment costs in making a drug available via exclusivity in the market and via patents. The next generation drugs will be even more complex and difficult to manufacture. If these are going to be available at affordable costs via commercially viable processes then the speed of drug development has to be increased while ensuring robustness and safety in manufacture. The research in this proposal addresses the challenging transition from bench to large scale where the considerable changes in the way materials are handled can severely affect the properties and ways of manufacture of the drug. The research will combine novel approaches to scale down with automated robotic methods to acquire data at a very early stage of new drug development. Such data will be relatable to production at scale, a major deliverable of this programme. Computer-based bioprocess modelling methods will bring together this data with process design methods to explore rapidly the best options for the manufacture of a new biopharmaceutical. By this means those involved in new drug development will, even at the early discovery stage, be able to define the scale up challenges. The relatively small amounts of precious discovery material needed for such studies means they must be of low cost and that automation of the studies means they will be applicable rapidly to a wide range of drug candidates. Hence even though a substantial number of these candidates may ultimately fail clinical trials it will still be feasible to explore process scale up challenges as safety and efficency studies are proceeding. For those drugs which prove to be effective healthcare treatments it will be possible then to go much faster to full scale operation and hence recoup the high investment costs.As society moves towards posing even greater demands for effective long-term healthcare, such as personalised medicines, these radical solutions are needed to make it possible to provide the new treatments which are going to be increasingly demanding to manufature.
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