The therapeutic stem cell and Advanced Therapeutic Medicinal Product (ATMP) market is continuing to develop. Over the last two years the focus of industry discussion groups within the UK has moved forward from research techniques during development to the challenges of GMP manufacturing these products. Once manufacturing issues are resolved focus will move onto the challenges of stem cell clinical trials.
The difficulties of obtaining approval from authorities to conduct the trials will be the main focus of the sponsor. With these challenges ahead, there may be little time to focus on the actual method of labelling, storage and distribution of the product to the trial sites.