Cambridge Biostability Limited (CBL) has announced that it has commissioned the commercial sterile spray drier for vaccines.
Once fully operational in the March 2006 the £1million facility will produce clinical trial material manufactured to the approved quality - accelerating the time to market - and providing a precursor for further large-scale stable vaccine production.
Dr Bruce Roser, Chief Scientific Advisor, CBL comments that there is already over demand from its partners for the facility, "Traditionally vaccines are made in a batch process, measles for example takes 3 days to manufacture and freeze dry, with spray drying this takes seconds and can run continuously until sufficient quantity is made."
"If all vaccines were made by spray drying we could overcome the problems of shortages, enabling production to be linked more precisely to demand."
CBL has developed a method of stabilising vaccines, which has been described as the holy grail of vaccine research.
Production at the facility will include material for a stable childhood pentavalent vaccine for which CBL was awarded a grant from the UK's Department for International Development.
It is anticipated that the production facility will shave a year off the development time, allowing clinical trials to start in 2008.
The £1 million investment will be installed at Nova Laboratories, Leicester; it will become operational in March and in full production by September 2006.
CBL has attracted £2.2m of funding to support the development of the "aseptic" spray drier which was made in Denmark by Niro and it is the first in the world to be made for vaccines.
Driers of this size are normally used for R&D purposes or small scale production of chemicals, pharmaceutical powders and specialised food products.
Dr Roser comments that it was important the first facility was built in the UK, "This is a radically new technology that will enable batches of 10,000 doses to be produced under CGMP (Current Good Manufacturing Process)."
"The plant allows us to address scale up issues and refine the equipment. The next sterile facility will be for commercial production of stable liquid vaccines and will be ten times bigger."
Cambridge Biostability was named 'Most Promising Angel Funded Business' by the British Angels Association in June this year, with a market opportunity of £5bn.
It has attracted one of the largest ever angel syndicates, and investors include individuals such as Asian businessman, Vijay Saggar, who is a supporter of the company's "third world first" business strategy.
Delhi-based Panacea Biotec is one of the first clients to benefit from the facility. The company has set up three new plants and four R&D centres of its own over recent years, in preparation for export to the US and European Markets by 2008.
With CBL's technology vaccines are mixed in a fluid of glass forming compounds and spray-dried to form microscopic spheres.
The dry vaccine is suspended in an approved inert liquid ready for injection, after which bodily fluids reactivate the vaccine.