Cell Therapy Regulatory Toolkit

The British Regen Industry Tool Set (BRITS) project (2010-2014) was focused on the commercialisation of cell therapy and regenerative medicine within the UK, and had an emphasis on building a set of tools that have the ability to streamline cell therapy process development, manufacturing, business development, and regulatory strategies. The project was a collaboration involving a number of project partners including UCL (London, UK), Lonza, LGC (Teddington, UK), Future Medicine (London, UK), LRMN (London, UK), and the NHS Technology Adoption Centre (now integrated into NHS England). It was funded by Innovate UK (then the Technology Strategy Board) under their Regenerative Medicine program: Value Systems and Business Modelling.

Two specific capabilities developed within the project were the Cell Therapy Regulatory Toolkits, devised and put together by LRMN, with assistance from Lawford Davies Denoon (London, UK) and Carpenter Group Consulting Inc (Seattle, WA, US). The toolkits are designed to inform users on licensing, consent, and banking requirements associated with different types of cellular products, and cover detail on applicable Regulations, product classifications, manufacturing requirements, possible exemptions, and available incentives. One toolkit pertains to the UK and EU regions, and a parallel site covers the US region; both were drawn up using information as accurate in 2014/2015.

Please note, LRMN and the participants in the BRITS consortium offer this tool 'as is', without any warranties or assurances about accuracy of the information included, particularly as the information contained is subject to changes by the relevant regulatory bodies. The tool does not necessarily reflect the views or recommendations of any of the different parties involved in the project, including Lonza. In case of doubt, users are encouraged to seek appropriate regulatory guidance by a qualified expert in the field.