Brussels, 10 Nov 2004
The European Commission has launched a new 11.5 million euro Integrated Project (IP) that seeks to reduce the cost of emerging biotech pharmaceuticals by identifying improvements in their production processes.
The AIMs (advanced interactive materials by design) initiative gathers 24 partners from industry, academia and other stakeholder groups from 12 European countries, under the coordination of Andrzej Górak from the University of Dortmund. It is supported under the 'nanotechnologies and nanosciences, knowledge-based multifunctional materials, and new production processes and devices' (NMP) priority of the Sixth Framework Programme (FP6). CORDIS News spoke to the University of Dortmund's Barbara Zeidler - the project's spokesperson - and asked her what the consortium hopes to achieve over the course of its four year collaboration.
The AIMs project, Dr Zeidler explained, is focused on finding improved methods for the production of monoclonal antibodies (MAbs). MAbs are laboratory-produced biomolecules, similar to human antibodies, but whose distinguishing feature compared to other drugs is their ability to bind to only a single type of molecule. Currently, MAbs are primarily used for diagnostic purposes, the most widespread example of which is the home pregnancy test.
However, given their high degree of selectivity, researchers are now seeking to use MAbs in the treatment of human diseases such as cancer, diabetes and HIV. 'Most current drugs don't just target the disease, they also attack healthy cells, producing unwanted side effects,' explained Dr Zeidler. 'These new biomolecules act more like our own bodies' proteins, and are much more targeted, resulting in fewer side effects.'
With an estimated 120 such MAbs currently being developed and tested, there is no shortage of possible new treatments in the pipeline. Yet the cost of producing these biomolecules is still extremely high, and given the prevalence of these diseases in the general population, existing production capacities fall woefully short.
The AIMs IP looks to address these issues by focusing its attention on the part of the production process, where the partners see the greatest potential for cost reductions. MAbs are produced in two stages: upstream and downstream. 'In the upstream process, the antibodies are built and you are left with a kind of 'soup' containing the target biomolecules and other impurities. The antibodies must then be purified and selected through downstream processing - and we are focusing on this stage,' said Dr Zeidler.
A number of different purification steps can be applied to the soup containing the biomolecules, including the use of membranes, chromatography and extraction techniques. The most effective purification of MAbs is commonly achieved through the use of target molecules, known as ligands. 'In the consortium we have both ligand producers and chemical engineers who specialise in the purification process - for the first time, the AIMs project will bring them together in an integrated way,' Dr Zeidler told CORDIS News.
In order to make their work more manageable, the partners have created six sub-projects within the overall IP. 'Sometimes researchers from different partner organisations will work together in the laboratory, and sometimes partners will receive training in each other's areas of expertise. Each organisation is involved in several of the sub-projects, however, which further encourages the exchange of information,' believes Dr Zeidler.
Socio-economic studies will also be undertaken to assess the impact of these new MAb treatments on patients' quality of life, as well as the general economics underlying the overall production process. And although the initiative has only been running since 1 April, Dr Zeidler revealed: 'We have had some encouraging results already, but I cannot give any details, as there may be intellectual property issue to consider - hopefully!'
Given some of the recent criticism levelled against Integrated Projects, notably in the recent Marimon report on the new FP6 instruments, CORDIS News asked Dr Zeidler whether the large consortium structure has presented any particular challenges. 'For this specific research topic, the IP is exactly the right instrument, as integration is the key to achieving our objectives,' she replied. 'The six sub-projects are akin to STREPs [specific targeted research projects], but without the overall IP framework the necessary information exchange between the 'STREPs' would not occur.'
'Administration for such a large project presents some challenges,' she admitted 'but up 'til now we have found a good way of working.' Dr Zeidler emphasises the benefit, when working with 24 partners from so many different countries, of having a single source of funding and administrative guidance, namely the Commission.
At present, Dr Zeidler believes it is too early to say whether they will achieve enough of their objectives to extend the initiative beyond its current four year timeframe, but given the early successes that the consortium has enjoyed, she remains hopeful that the AIMs project can play a vital role in ensuring that these emerging therapies can be used to treat the highest possible number of patients who need them most.
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