Objective
This proposal is prepared with the help of an Exploratory Award which included a Research Feasibility Study. This project addresses the increasing need for validated processes capable of removing and/or inactivating agents causing Transmissible Spongiform Encephalopathies (TSEs). TSEs like BSE and scrapie have already caused enormous damages to economy, and are becoming a serious matter of concern to the pharmaceutical industry, as the transmission of Creutzfeld Jacob Disease (CJD) through biologicals like blood derived products cannot be ruled out. As screening for TSE causing agents, especially in materials with low infectivity, is not practically possible, there is a strong need for VALIDATED processes shown to remove and/or inactivate TSEcausing agents. The concept of this project is to study some of the existing methods by applying them to processes and products defined by the participants as economically important.
In order to increase the range of products to be tested, a 3 step approach is chosen:
1. More than 50 process steps with a potential to remove or inactivate TSE causing agents are investigated for feasibility. Only those steps which leave the target product unchanged (in biological activity and physico chemical characteristics) and which can be scaled down successfully, are spiked with infectious material and;
2. Tested IN VITRO. using Westem Blot and DELFIA assay. These quick tests should indicate those process steps where considerable inactivation or removal has occurred;
3. IN VIVO determination of infectivity is only done with the most successful samples. Product characterisation is done by the industrial partners during the first year. Spiking experiments will be done at the RTD contractor, where ali IN VIVO testing is done. Further characterisation of the products, implementation and integration of process steps into largescale production, and registration of the new, TSE free products by the industrial participants will require a further period of 2 years.
Fields of science (EuroSciVoc)
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Programme(s)
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Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
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Funding Scheme
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Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
8045 Graz
Austria
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.