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
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).