A forest-inspired fix helps vaccines beat the heat
Vaccines work through various active agents, including weakened microorganisms, proteins or nucleic acids such as mRNA. But many of these, including vaccines against tetanus, diphtheria and COVID-19 degrade in high temperatures, requiring an unbroken cold chain as low as -80 °C from manufacturer to clinician. Cold chain logistics are responsible for up to 80 % of the expenses associated with vaccine programmes. Working in his lab at the University of Helsinki in Finland, GLOBEVAC project coordinator Vincenzo Cerullo(opens in new window) cites the nearby forests as inspiring a potential solution. “I became more aware of the circularity of nature and thought we could learn from this,” he says. The project, supported through the European Research Council(opens in new window) (ERC), developed sustainable, cellulose-based biopolymers derived from wood waste which form a protective case around fragile biological products, including vaccines. “To the best of my knowledge, we are the only ones pursuing this approach,” adds Cerullo.
Proprietary vaccine stabilisation technology
GLOBEVAC used its unique proprietary formulation to ‘encase’ vaccines and protect them against heat, working in vivo in preclinical models, with a range of enveloped and non-enveloped viral vectors. The formulation is based on a biodegradable nanocellulose material already commonly used in pharmaceutical products. Building an approach designed to integrate into existing pharmaceutical manufacturing processes, the vaccine is combined with the GLOBEVAC formulation and processed into a stable solid form, which is later reconstituted for use by clinicians. “The protective matrix prevents the aggregation, protein unfolding and membrane damage that normally occur during storage or transport, preserving the natural structure and biological activity of the vaccine or biologic,” explains Manlio Fusciello, CEO of GlobeVAC(opens in new window), a spin-out company aiming to commercialise the technology. “Compatible with existing pharmaceutical manufacturing, the process is simple and scalable for temperature-sensitive biologics.” To assess its stabilising capacity, samples of viral and non-viral vaccines were stored at a range of temperatures up to 40 °C, representing real-world storage and transport scenarios. The vaccine’s stability was monitored for several months. These studies evaluated the preservation of particle size and distribution, protein integrity, antigen stability, biological activity and functional performance after reconstitution, as well as immunogenicity and efficacy. These tests helped determine whether vaccines preserved with GlobeVAC’s technology retained their ability to induce protective antibody and T-cell responses after storage, compared to freshly prepared vaccines and degraded controls. “Our proof of concept vaccines, stored for weeks at elevated temperatures, remained comparably effective to those kept frozen,” remarks Cerullo. The project successfully preserved viral, mRNA-LNP and live attenuated vaccines along with outer membrane vesicles, antibodies and bacteria, demonstrating stability for up to 6-8 months. In the future, the methodology could be extended to protect medications which need refrigeration, as well as functional enzymes and monoclonal antibodies.
Getting human and animal products market-ready
GLOBEVAC’s success demonstrates how the ERC can drive forward the EU’s goals of innovation and competitiveness, and EU4Health’s mission of strengthening global health resilience(opens in new window). GlobeVAC is protecting its technology through a growing intellectual property portfolio originating from University of Helsinki research. The company, which attracted EUR 450 million in pre-seed funding, is now focused on developing two biostable products, one for human health, and a veterinary medication for pathogenic bacterial infections. The signs are promising. “I recently met with an ambassador of an African country who was very interested in our progress, and we see a clear gap in the veterinary market which currently sometimes relies on liquid nitrogen to transport vaccines,” adds Cerullo.
