Cambridge Biostability invests in spray dryer 'first'
The world's first commercial sterile spray dryer for vaccines has been commissioned by UK company Cambridge Biostability (CBL). The £1m investment will be installed at Nova Laboratories in Leicester; where it will become operational in March and in full production by September 2006. It will produce clinical trial material manufactured to the highest approved quality and provide a precursor for further large-scale stable vaccine production.
CBL has attracted £2.2m of funding to support the development of the 'aseptic' spray dryer, which was made in Denmark by Niro. Dryers of this size are normally used for r&d purposes or small-scale production of chemicals, pharmaceutical powders and specialised food products. 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 facility will shave a year off the development time, allowing clinical trials to start in 2008.
'Traditionally, vaccines are made in a batch process - that for measles, for example, takes three days to manufacture and freeze dry. With spray drying this takes seconds and can run continuously until sufficient quantity is made,' said Dr Bruce Roser, chief scientific advisor, CBL. 'If all vaccines were made by spray drying we could overcome the problems of shortages, enabling production to be linked more precisely to demand.'
Most vaccines currently need to be refrigerated or they become inactive, but CBL has developed a revolutionary method of stabilising them. The 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.
'This is a radically new technology that will enable batches of 10,000 doses to be produced under cGMP,' added Roser. '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.'