Cambridge Biostability invests £1M in spray dryer
first commercial sterile spray dryer for childhood vaccines, in
which the £1 million (€1.5 million) facility will produce clinical
trial material providing a precursor for further large-scale stable
vaccine production.
Traditionally vaccines are made in a batch process, which is a laborious and time-consuming process. Measles, for example, can take 3 days to manufacture and freeze dry.
With spray drying the process can be speeded up immensely and can run continuously until sufficient quantity is made. Spray drying is faster than traditional drying processes and is continuous rather than batch production.
If all vaccines were made by spray drying, the problem of shortages could be addressed enabling production to be linked more precisely to demand.
Production at the facility will include material for a stable childhood pentavalent vaccine.
It is anticipated that the production facility, located at Nova Laboratories, United Kingdom, will become operational in March and in full production by September 2006 with clinical trials expected to commence in 2008.
The development of the "aseptic" spray dryer which was made in Denmark-based 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.
"This is a radically new technology that will enable batches of 10,000 doses to be produced under Current Good Manufacturing Process (CGMP)," Dr Bruce Roser, Chief Scientific Advisor, CBL.
"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," he added.
CBL's technology has the major advantage of not requiring a cold chain. Currently 50 per cent of all vaccines are wasted partly due to suspected or real temperature damage. The cold chain has an estimated cost of $200-300m per annum.
In addition, the microspheres in the technology make the vaccines inert so they can easily be multivalent and the number of booster doses reduced.
Most vaccines currently need to be refrigerated or they become inactive, CBL has developed a revolutionary method of stabilising vaccines, which has been described as the holy grail of vaccine research.
It is estimated by the World Health Organisation (WHO) that currently nearly half of all global vaccines are wasted partly due to suspected or real temperature damage and as a result millions of children and adults go without life-saving vaccinations.
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.