Objective Ingenza will address an unmet industry need at the European level for an enabling biologics manufacturing and refinement platform targeting difficult-to-express protein structures and/or hard-to-handle potent products that requires novel, efficient, low volume manufacturing. This is a niche high-value market but the customisation and flexibility needed to address such complexity means the market is not of interest to larger established Contract Development Manufacturing Organisations. Ingenza will deliver and demonstrate a novel synthetic biology (SynBio) driven manufacturing platform that is EMA and FDA certified for GMP production of investigational and commercial biologics. This includes transitioning SynBio tools developed for industrial biotechnology towards addressing opportunities in the growing biopharmaceutical sector (CAGR 9.5%); delivering innovative biomanufacturing capabilities beyond the current state-of-the-art. To achieve this goal Ingenza will deploy its inABLE® suite of proprietary SynBio tools including those for high throughput gene cloning, efficient strain screening/construction and effective bioprocess development - all integrated with state of the art single use biofermentors and downstream process technologies. Ingenza’s biomanufacturing process is at TRL 6 moving towards TRL 9. The project is supported by five novel biologics developers in the EU and US, one of which will provide the case study at Phase 2 using an microbial cell factory. The Phase 1 project aims to (i) define the activities required to achieve Good Manufacturing Practice compliance for a first highly potent target biologic, (ii) demonstrate scale up, (iii) test the market to ensure a robust business model and (iv) confirm freedom to operate. Ingenza expect to reach the market in 2019 initially creating 10 high value biomanufacturing jobs. Predicted revenues should achieve an ROI of 1:9 after 6 years and 27new jobs. Fields of science engineering and technologymechanical engineeringmanufacturing engineeringengineering and technologyindustrial biotechnologynatural sciencesbiological sciencessynthetic biologymedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugssocial scienceseconomics and businessbusiness and managementbusiness models Programme(s) H2020-EU.2.1.4. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Biotechnology Main Programme H2020-EU.2.3.1. - Mainstreaming SME support, especially through a dedicated instrument Topic(s) SMEInst-03-2016-2017 - Dedicated support to biotechnology SMEs closing the gap from lab to market Call for proposal H2020-SMEInst-2016-2017 See other projects for this call Sub call H2020-SMEINST-1-2016-2017 Funding Scheme SME-1 - SME instrument phase 1 Coordinator INGENZA LIMITED Net EU contribution € 50 000,00 Address ROSLIN INNOVATION CENTRE, CHARNOCK BRADLEY BUILDIN EASTER BUSH CAMPUS, BUSH FARM ROAD, EH25 9RG Roslin United Kingdom See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Scotland Eastern Scotland East Lothian and Midlothian Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 71 429,00