Horizon 2020

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

Scope & Objectives

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 less than €2.60/assay, saving 61% in operational costs.

The Project 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).


Partners

Fida Biosystems ApS
CVR no. 34687870
Fruebjergvej 3
2100 Copenhagen

Elvesys SAS
Co. no. 53130117400045
83 Av Philippe Auguste 
75011 Paris

FHNW University of Applied Sciences and Art
Hofackerstrasse 30
CH – 4132 Muttenz

Sarl Novoptim
Co. no. 45196837400020
5 rue Lamennais
75008 Paris


Funding and timing

This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 878727.

It started on December 2019 and runs until November 2021.

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