Allogeneic MSC for tissue engineering

Added: 14th November 2016

CellData Services is developing a long-standing collaboration with a UK-based regenerative medicine company, providing regulatory affairs support and expert guidance on a long-term basis. The company is adapting their core tissue engineering technology from autologous to allogeneic cells. This is a critical step in building a commercially viable advanced therapy offering, which will allow more cost-effective manufacture and distribution whilst maintaining clinical safety and efficacy. The company has invested significant resources to initiate clinical development of their autologous product, so we are helping to maximize the relevance of existing data to ensure a streamlined development process whilst meeting all of the regulatory authorities' expectations. In particular, application of the risk-based approach to development, a specific provision for ATMPs within European legislation, is being used to optimise the non-clinical development programme.

"I would and have (!) recommended Alison to other Companies as a result of her excellent support for Azellon and we have worked together on other projects, notably the set-up and conduct of a Phase I/IIa patient trial using a combination drug-device (another area of expertise for Alison)."

Helen Delahaye - Chief Operations Officer - Azellon Ltd, UK