Government-backing for a large-scale cell therapy centre is justified because it will help developers navigate the “valley of death” in which many early-phase projects fail says the team planning the new manufacturing hub.
This week UK Chancellor George Osborne announced that the Government will invest £55m ($90m) in a cell therapy centre to provide developers with a site capable of making sufficient quantities of cell therapies of late-phase trials and commercial production.
Emma Palmer Foster, spokeswoman for management organisation Cell Therapy Catapult, told BioPharma-Reporter.com that: “There aren't at present in the UK any manufacturing facilities capable of producing cell therapies in the volumes needed for late-stage clinical trials and the market.
“The Cell Therapy Manufacturing Centre will provide domestic companies with just that, so that they have no need to go overseas to establish a commercial and manufacturing presence. Equally, for US or other international companies seeking a European manufacturing foothold for commercial activities in the region, the Centre will be that place.”
This was echoed by BioIndustry Association CEO, Steve Bates, who told us that: “Although the UK's small-scale academic facilities are an excellent source of materials for early-stage clinical trials this capacity will soon be filled as the pipeline of cell therapies matures.”
Flexibility is key
The project is still at the planning stage. The location for the centre has not been selected and the precise manufacturing capabilities and capacity it will offer – other than that it will produce “tens of thousands of doses per year” - have not been decided.
But what is clear is that - like the national biomanufacturing hub being built in Darlington - the plan is to establish a facility that is flexible enough to accommodate a wide range of customers from across the cell therapy sector.
Palmer Foster said that: “Considerable flexibility will be required as each organisation using the facility will have different requirements.
She added that: “As a commercially-led centre of excellence for cell therapy, the Cell Therapy Catapult is focused on innovative solutions and it's a key part of our role to keep up to date with technology, scientific, clinical and regulatory developments.”
Elsewhere in his Budget of “hard truths ” Osborne set out a programme of spending cuts – public sector pay limits will remain and National Health Service (NHS) and school budgets will be frozen – as part of an ongoing austerity programme.
However, while cell therapy developers are trying to develop products for profit, the sector does deserve Government support according to Cell Therapy Catapult’s Palmer Foster who cited the complexity of making such treatments and the potential knock-on benefits for the UK as justification.
“The Government is supporting the cell therapy industry as a consequence of two factors - the fantastic cell therapy expertise in the UK around early-stage research, and the market failure that has previously made it hard for the industry to develop here.
“This market failure is the lack of expertise in the translational phase of research - the 'valley of death' - through which early-stage research progresses to become a less risky more investible proposition. In the UK, there are translational hurdles in the business, clinical and manufacturing parts of the development chain.”
“Growth of the cell therapy industry in the UK should lead to longer healthier lives as a result of the treatments produced, domestic and inward investment as well as skills creation and job development.”
BioIndustry Association CEO Steve Bates agreed, adding that: “Commercial manufacturers have been reluctant to commit to establishing new facilities without projects for the facilities.
“The Cell Therapy Manufacturing Centre will provide the UK with the manufacturing facilities recommended in the House of Lords report, and will help retain cell therapy manufacturing expertise and jobs in the UK.”