The e-FabRIC project aligns with the EU’s pandemic preparedness plan by supporting the development of broad-spectrum antiviral therapies to address unmet public health needs. Its goal is to provide a ready-to-use therapeutic solution capable of tackling major societal and health challenges.
e-FabRIC will implement a novel hyperimmunization strategy to produce high-titer equine immunoglobulins with broad neutralizing specificity against viruses in the sarbecovirus subfamily. These antibodies will be processed as purified F(ab’)2 fragments, a well-established pharmaceutical product with a strong safety record in humans.
The broad neutralizing activity results from immunizing horses with a nanoparticle “mosaic antigen” displaying up to eight different sarbecovirus receptor-binding domain (RBD) subunits, combined with the natural immunogenetic diversity of horses. Polyclonal antibodies produced this way have intrinsic advantages, such as high avidity and recognition of multiple adjacent epitopes on the nanoparticle, offering broader coverage compared to monoclonal antibodies.
Unlike monoclonal antibodies, which bind only a few precise epitopes and are prone to viral escape, the polyclonal F(ab’)2 fragments provide a multivalent approach that is more cost-effective and resilient against mutations.
To ensure European sovereignty, the entire production chain—including antigen manufacturing, hyperimmunization, and GMP processing—will take place within the EU. e-FabRIC will also establish a comprehensive regulatory pathway by developing all necessary analytical methods early in the process.
The project aims to collaborate closely with regulatory authorities to define the best approval strategy. The FBT manufacturing platform will produce GMP-grade therapeutic F(ab’)2 fragments for stockpiling, enabling immediate clinical deployment during epidemics or pandemics with a safe, effective, and rapidly available treatment option.
