REGenableMED is an ESRC-funded project examining the dynamics of innovation within the field of regenerative medicine and recently produced a policy briefing on manufacturing in this field.
The REGenableMED project (University of York; York, UK) publishes a series of short Policy Briefings related to its ESRC-funded project on regenerative medicine, including a recent one related to manufacturing and scale-up. This Policy Briefing shows how scale-up will pose radically different challenges to the ‘Fordist’ model seen in the mass production of drugs. There are particular difficulties being experienced in adapting the conventional chemicals-based regulatory system to biological products and in developing standards and guidelines for cell manufacturing.
The report recognizes the role that the new Cell & Gene Therapy Catapult Centre (Stevenage, UK) will play but also asks the important question of how will this relate to the regional Centers for Cell and Gene Therapy Treatment that are being advocated by a November 2016 report of the Advanced Therapies Manufacturing Taskforce, a group launched by the Medicines Manufacturing Industry Partnership (UK). The Medicines Manufacturing Industry Partnership was established jointly by the UK Government and the biopharmaceutical industry in 2014.
Among a number of policy recommendations, two are especially important as they appear to be off the radar at the moment. Work needs to be done to clarify the organizational structures that might be developed to reduce manufacturing costs while maintaining quality and safety. Additionally, scenarios for the likely size and profiles of clinical populations treatable through different manufacturing modalities and scales should be developed to support national planning.
- Advanced Therapies Manufacturing Taskforce. Advanced Therapies Manufacturing Action Plan: Retaining and attracting advanced therapies manufacture in the UK. November, 2016.
- The REGenableMED Project (University of York, UK). https://www.york.ac.uk/satsu/current-projects/regenablemed/