Technology
Fabentech’s solutions are based on the production of polyclonal antibody fragments. These highly purified potent antibodies recognise and bind to the virus or toxin, thereby stopping disease progression. These immunotherapies can effectively neutralise biological agents and a wide range of their potential variants.
Polyclonal Antibodies
Fabentech’s cutting-edge technology produces highly purified polyclonal F(ab’)2 fragments – smaller antibody molecules of about 110kDa – that retain the specificity of intact antibodies for antigen binding. These fragments offer several advantages, including better tissue penetration and reduced immunogenicity.
Mimicking the natural immune system, polyclonal antibodies have proven to be effective against rapidly mutating pathogens or toxins with multiple variants, attacking the antigen on several fronts.
Our product, FabenFLU®, has demonstrated the ability to neutralise over 20 viral strains of the highly pathogenic avian flu virus H5N1. Our polyclonal antibodies have shown efficacy against a variety of acute viral diseases and toxins, including H5N1 influenza, Ebola haemorrhagic fever, Covid-19, and a plant-based toxin, making them a reliable treatment for medical emergencies.
- Specific and potent neutralising activity on toxins and viruses
- Broadly neutralising antibodies with multi-epitopes binding sites
- Multi-targeting and cross-neutralisation to remain effective against variants
- Reduce the risk of immune escape
- Faster and better tissue penetration than whole antibodies
- Low immunogenicity of F(ab’)2 fragments
The FabShield® development platform
The FabShield® technology platform is a risk-free, safe, tested, and validated polyclonal antibody platform and has already proven successful in developing treatments against a range of deadly viruses and toxins.
Our integrated R&D and proprietary manufacturing site enable us to rapidly develop new medical countermeasures, ensuring that we are always prepared to face unpredictable risks.
By mostly targeting serious, life-threatening conditions, caused by exposure to lethal biological substances, our product developments rely on the Animal Rule regulatory procedure, allowing us to bypass time-consuming phase 2 and phase 3 clinical trials. This approach drastically reduces costs and risks associated with traditional product development.
As a result, we are uniquely positioned to offer reliable, cost-effective, and rapid solutions to address some of the most pressing medical challenges of our time.
Fabentech rigorously “designs” and selects high-quality antigens.
Antigens are used to produce antibodies of interest through specific and proprietary hyperimmunisation protocols.
Polyclonal antibodies are collected in plasma that are selected and standardised through strict quality controls procedures. Selected plasma constitutes the raw material that can be stored for years in a plasma bank.
Polyclonal F(ab')2 fragments are produced by cleaving IgG antibodies and are purified in our GMP manufacturing site.
Immunotherapies for human use can be stockpiled for years and ready to be deployed in case of medical emergency.
- Demonstrated safety on humans and efficacy against several viruses and toxins
- Cost-effective developments comparing to monoclonal solutions
- Fast drug development with first-in-human study within 12-18 months
- Robust and reproductible platform recognised by many worldwide medicine agencies
- Fast time-to-market through accelerated regulatory pathways
- Flexible platform able to address multiple targets
Production
Located in Lyon, France, Fabentech owns a 1,000sq.m GMP ready production site which performs polyclonal antibody purification on an industrial scale. Fabentech is one of the few European biotech companies that is able to produce this type of solution while ensuring compliance with the strictest international standards. This constitutes a major asset in the struggle against emergency health situations. This robust and reproductible manufacturing process enables switching lines to produce different types of treatments and adjust its production level with great flexibility.
- GMP ready bio-manufacturing site
- Ever-warm production capacities of polyclonal F(ab’)2 fragments within few months
- Facilitated biomanufacturing scale-up with controlled costs
- Proven transferability of the manufacturing processes
- Flexible process with switching line to produce different treatments in record time