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Scale-up of our disruptive antibody analytical platform based in flow-induced dispersion analysis (FIDA) to increase efficiency in the research of new antibodies and vaccines

Project description

Novel flow-induced dispersion analysis analytical platform for antibody and vaccine research

Therapeutic antibodies and vaccines have become indispensable components of modern medicine. Research and development of new vaccines is very costly and involves years of tests from preclinical phase to registration, and there is a high rate of failure. The EU-funded FIDA project is developing an innovative analytical platform based on flow-induced dispersion analysis to simplify the whole chain of immunological tests and bring them into a native conditions environment. This new powerful methodology promises dramatic increase in measurements' sensitivity and significantly shorter time for assays to be completed, and it will require a much smaller sample volume. The current phase of the project focuses on the global research antibodies market and the vaccine research and development market at the preclinical stage.

Objective

Therapeutic antibodies have rapidly become a major component of modern medicine. The global research antibodies market size is expected to reach €3.8bn by 2025. However, exiting research tools have not been able to eliminate Hyper-Sensitivity Reactions (HSRs) against the biologic drug by the patient’s immune system. HSRs are estimated to occur in 10-15% of hospital patients and can arise for any biologic, mostly antibodies.
Antibodies are also important in the R&D of new vaccines. To test vaccines, it is necessary to follow the generation of auto-antibodies to verify that the vaccine is working well. This analysis is done with the same tools used in the antibodies research, and with the same drawbacks: artificial assays based on non-native sample materials. Vaccine R&D is immensely costly: up to €400m over a 11-year timeline is standard for a completely new vaccine and overall failure rate from preclinical through to registration is 94%.
FIDA is a patented solution that simplifies and standardises immunological measurements under native conditions. We go from 15 treatment steps on current platforms to a single step with FIDA. FIDA is a powerful methodology for quantifying and characterising antibodies and antibody binding with up to 10-times higher sensitivity than present tools. Assays take 5-20 minutes to run, 90% less than alternatives, with full walk-away automation as-standard. FIDA’s simplicity allows to set-up assays versus new targets within 1 day versus 10 days with current tools. It is based on a microcapillary system that needs <3μl of sample, 16-times less than today’s methods to support parallel testing of multiple early-pipeline drug samples. FIDA uses up to 10μl of standard reagents and running costs are €2.60/assay saving 61% in operational costs.
FIDA focuses on both the global research antibodies market and vaccine R&D market at pre-clinical phase (in which certification as a diagnostic/prognostic device is not needed).

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

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.

IA - Innovation action

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-EIC-FTI-2018-2020

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Coordinator

FIDA BIOSYSTEMS APS
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 394 621,20
Address
FRUEBJERGVEJ 3
2100 Kobenhavn
Denmark

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Danmark Hovedstaden Byen København
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost

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.

€ 1 992 316,00

Participants (3)

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