1st October 2015 – 31st March 2016
Regenerative medicine has been identified by the Government as a priority technology for UK competitiveness and a healthy nation. Cell and Tissue-based therapeutics (CATBTs) are a key category of these and pose significant challenges to traditional modes of manufacturing scale-up for commercialisation. This study aims to examine a range of alternative models of redistributed manufacturing for both autologous and allogeneic CATBTs and identify those that offer the highest probability of success for future business. Five possible models have been identified (scale up, scale out, franchise, hub, in-hospital) and will be used to frame four work packages;
- Regulatory Route to Supply with Confidence
- Investigation of Business Models from Biological / Engineering / Business / Supply Chain Perspectives
- Technical Comparability of Equipment
- Accommodation and Exploration of Variation
The outcomes from this endeavour will include detailed research questions with outlined project proposals, indication of technology gaps for adoption of particular business models, framework models of operation to an internationally-recognised standard and potential business models described with initial cost roll-up analysis. The outcomes will inform the research agenda for the UK to provide enabling technology for the preferred business formats.