The ATMP Manufacturing Community (amc).

ISSN 1746-0751 Regen. Med. (2012) 7(3), 1–5 1 10.2217/RME.12.9 © 2012 Future Medicine Ltd A successful cell therapy industry is extremely important to the UK economy because it offers significant benefits to patients and to the National Health Service and because it provides an opportunity to grow a knowledge-based industry that can remain largely local. There are currently 26 cell therapy companies in the UK. If the global cell therapy market is to grow as predicted by Mason et al. [1], then it will be worth US$5.1 billion by 2014. Additionally, there is great potential for the provision of related services such as raw materials supply, manufacturing equipment, quality control and logistics. Cell therapy scientific research and development in the UK is world leading [101], with notable achievements beginning as early as 1978 with the world’s first ‘test tube baby’ [2], and more recent successes such as the Macchiarini trachea [3], limbal stem cell transplantation [4] and stem cells for heart failure [5]. Scientists in the UK are developing stem cell therapies to treat diseases of all prevalences, ranging from orphan diseases such as epidermolysis bullosa [6], to those that affect much larger proportions of the population, such as age-related macular degeneration [7]. Aside from blood and bone marrow processing, cell therapy manufacture is still in its infancy. Currently, the processes used to produce cells for preclinical and early-stage clinical studies are more suited to the bench than they are to full-scale manufacture. There is a translational gap between science (research and development) and implementation (routine manufacture) that requires a bioprocess-engineering approach which is often ignored by those developing early-stage cell therapy products. In the UK, there is a strong cell therapy community, and frustrations about this translational gap were routinely voiced at a number of collaborative events (e.g., Newcastle Biomedicine Sandpit, RegeNer8, Clinical Needs Workshop, London Regenerative Medicine Network [LRMN] and related Technology Strategy Board projects). Organically, the need for a working group to address these needs emerged, and in September 2010 the Advanced Therapy Medicinal Product (ATMP) Manufacturing Community amc Institutional Profile