The £34.25m (€49.5m) NBC, based in Liverpool, has been set up to support the UK's biotechnology industry by providing high-quality process development and contract manufacturing alongside a government-run £3m access fund that will share the cost of producing clinical trial materials for qualifying companies.
This will help smaller companies - those with a good product idea but without the funds to pay a contract manufacturer to make enough of the compound to take it into clinical trials. Venture capital funding is often not available to these small companies, as these investors often require some proof-of-principle data before backing a project.
Access fund up and running in April
This access fund will start looking at applications at the beginning of April, according to Derek Ellison, business development director of Eden Biodesign, the company charged with designing and operating the NBC. Meanwhile, the first companies interested in making use of the facility have started to visit the site, and Eden is now offering free consultancy to UK biotechnology small and medium-sized companies until the end of the year to help companies advance their projects into the clinic.
While only qualifying UK companies can qualify for help via the fund, Ellison stressed that the services of the NBC will be open to companies around the world, particularly as the current stable of UK biotech firms are probably insufficient to keep the centre operating at capacity for the next three years. The unit could help support not only the UK but also the wider European biotechnology sector, which shrank for the first time in 2003 after years of growth, according to a recently-published report by Ernst & Young.
In-PharmaTechnologist.com visited the facility to get an update on progress and found construction well advanced and on target for the early-2006 start date. Construction of the building should be complete by March or April, and most of the equipment will be in place by June/July and validation is scheduled for completion in early December.
The facility has been designed for flexibility - it comprises three process development suites and three Good Manufacturing Practice units, all of which are isolated from each other so multiple projects can be carried out simultaneously - as well as analytical development and quality control labs and office space.
The unit can also handle microbial, mammalian and viral manufacturing and will make extensive use of disposable manufacturing to keep maintenance costs down and reduce the risk of contamination, said Ellison.
During the design process, Eden picked 10 of the most difficult manufacturing processes in biopharmaceutical production and conducted challenge studies to make sure that the NBC could accommodate them all. As a result, Ellison is confident that the facility will be capable of handling the production of 95 per cent of all products tipped to come out of drug discovery and preclinical development in the five to 10 years.
The NBC is thought to be the first initiative of its type in Europe, and perhaps even the world, but already looks to be inspiring imitation in other countries. The Canada government has already asked to see a copy of the business plan for the plant, while interest has also been expressed by Australia and Japan.