Consortium AIMs to cut MAb production costs
identify ways of improving the production of biologic drugs and
cutting the cost of treatment.
The AIMs (Advanced Interactive Materials by design) initiative has brought together 24 partners from industry, academia and other organisations from 12 European countries and is supported by Sixth Framework Programme (FP6) funding, according to Bayer, one of the collaborators in the project.
The four-year project, coordinated by Andrzey Gorak of the University of Dortmund in Germany, aims to find improved ways of making monoclonal antibodies (MAbs), which are starting to arrive onto the market in greater numbers as treatments for human diseases.
The cost of producing monoclonal antibodies is high, and this is because setting up and validating a production facility is expensive, and there is also said to be too little capacity in the marketplace to meet the anticipated demand of the large numbers of MAb-based drugs coming through development.
MAbs are produced in two stages: the upstream process, in which antibodies are produced by cells in a reaction vessel, and the downstream process which focuses on separating and purifying the MAb from the mixture. This separation and purification stage is estimated to make up 50 per cent of he total cost of goods for biological drugs, so it is this stage that the AIMs initiative is planning to improve.
"The overall goals are to cut process development time by half and to reduce cost of goods by a factor of 10 to 100," according to Dr Gorak.
The project will look at a range of purification technologies - including membrane filtration, chromatography and ligand binding - and try to develop ways of integrating them to speed up and increase the efficiency of the process.
One goal is to develop and synthesise supports that can be 'functionalised' with affinity ligands in order to purify target biomolecules with high efficiency and productivity, according to Dutch contract research organisation Syncom, which will be tasked with designing soluble supports for liquid/liquid extraction systems.