in Development by Norvax AS at Norsk Vaksinefabrikk and SINTEF

Executive Summary

The objective of Norvax AS is to realize production of mRNA-based vaccines and therapeutics, and to produce its own mRNA products. A key element of mRNA vaccines is the Lipid Nanoparticle (LNP), which envelops and stabilize the mRNA. Norvax will cooperate with SINTEF to establish the LNP formulation for the mRNA Vaccine Platform by Norsk Vaksinefabrikk. The project will last for 2.5 years. mRNA vaccine technology has proven successful for Covid-19 vaccines, and the establishment of an mRNA product manufacturing facility would create a novel and competitive market opportunity for Norvax and Norway. The goal of the NORVAX-LNP project is the development of a mRNA-LNP platform for mRNA formulation, with potential superiority in terms of stability and shelf-life. mRNA vaccines are proving to be safe and effective; a challenge is the requirement for cold storage and transportation due to stability issues. The innovation output from this project will result in sustainable value creation as the mRNA-LNP platform will be key for Norvax to move towards realization of the first mRNA product manufacturing facility in Norway, and the development of new and stable mRNA products, including vaccines. Norway has world class academic research groups related to vaccines and immunology, and this mRNA-LNP platform will provide the additional capacity needed to commercialize academic and technology transfer offices (TTO) generated projects. An international benefit of the mRNA-LNP platform is the role it plays in developing stable mRNA products that can be exported to LMIC (Low- and Medium-Income Countries) with minimal storage and transportation challenges. It will enable Norsk Vaksinefabrikk to grow the international export business with the mRNA products, including vaccines, and contract manufacturing services for domestic and international customers.

New collaboration between Norvax and SINTEF

In June 2021 The Research Council of Norway granted an innovation project that made it possible for SINTEF and Norvax to start a project collaboration. Project Title: “Development of a lipid nanoparticle platform for mRNA Formulation”. Norvax will cooperate with SINTEF to establish the LNP Formulation for the mRNA Vaccine Platform by Norsk Vaksinefabrikk by Norvax. The project will last for 2.5 years. The project will develop a novel Lipid Nanoparticle (LNP) Formulation to be used in the mRNA Vaccine Platform by Norsk Vaksinefabrikk. The scientific competence and technical experience of the researchers at SINTEF is transformative for Norvax to quickly develop the mRNA Vaccine Platform for open development of new mRNA vaccines by members of the mRNA UCV Consortium, and Vaxcomm – The Vaccine Commons, and to help enable Norsk Vaksinefabrikk to grow the international export business with the mRNA UCV product and contact manufacturing services for domestic and international customers.

Developing lipid nanoparticles that protect the mRNA molecular payload

mRNA is the body’s messenger molecule that instructs cells which proteins to produce. Proteins are central to all life and are functionally required for most biological processes in the body.  For the mRNA Universal Coronavirus Vaccine (mRNA UCV) product, when a person is injected with the mRNA UCV molecules, the genetic code of specific harmless “spike” protein segments, and other “conserved” targets of the virus, are delivered into the cell. The mRNA UCV molecules then instructs the body’s cells to make copies of the specific viral proteins. The immune system is now well understood to recognize these proteins as a foreign virus and build up immunity, as is the current case for successful mRNA vaccines for COVID-19. If the person later gets exposed to variants of the SARS-VoV-2 virus, the immune system will be far better prepared to respond to the viral infection. However, mRNA molecules alone are fragile and would be quickly broken down by the body’s defenses. For delivery of mRNA molecules into the cell, the commonly understood solution is to encapsulate mRNA in Lipid Nanoparticles (LNPs) that protect the mRNA from degradation. This is how the mRNA molecules of the current COVID-19 mRNA vaccines reach the cells, undamaged, whereby the mRNA molecule is expressed into the specified proteins to enable the immune response against SAR-CoV-2 viruses.

Safe and effective Covid-19 mRNA vaccines; a proven path toward transformative new medicines

Norvax plans to develop the mRNA Universal Coronavirus Vaccine (UCV) with SINTEF’s scientific support in the lipid nanoparticle (LNP) innovation project supported by The Research Council of Norway. SINTEF ‘s main role will be to create new and stable LNP formulations for mRNA at laboratory scale. It will be making many types of nanoparticles with different formulations. These various formulations are then characterized and mapped to include size and chemical properties. Since mRNA vaccines and the use of nanoparticles in medicine technology is a completely new technology, there are currently no standardized methodology for characterization. An important task during this collaboration will be to develop new and adapt existing methodologies so that we are able to identify the characteristics required. An important requirement for this methodology is that it is transferable and can function as a quality control in an industrial vaccine production, when vaccine manufacturing is to be scaled up. Throughout the project, SINTEF will continuously adapt methodologies with upscaling objectives to lay a robust foundation for the industrial vaccine production at the Norsk Vaksinefabrikk by Norvax. The new and stable LNP nanoparticles will be tested in cell cultures. There, SINTEF will rule out any toxic effects and investigate how efficiently the LNP Formulation is able to deliver functional mRNA into the cells. The formulations that are non-toxic and can deliver the most mRNA as efficiently as possible will then be tested in vivo to determine if they are suitable for mRNA vaccines of any diverse mRNA molecule specified for the particular target including infectious diseases, therapeutics and cancers.

An mRNA Vaccine Platform for mRNA vaccine innovations and pandemic preparedness innovations

COVID-19 mRNA vaccines have transformed the global scientific technology toolbox for fighting the current pandemic and future pandemics. The COVID-19 pandemic has put pandemic preparedness to an extreme test. It is now obvious to all that the world must increase preparedness for the inevitable emergence of future pathogens – to prevent the next pandemic. Norvax is establishing Norsk Vaksinefabrikk, a new vaccine factory in Sandefjord, Norway, for Norwegian vaccine manufacture of the mRNA UCV for global export and to help strengthen pandemic preparedness innovations. The development of the mRNA Vaccine Platform by Norvax in cooperation with SINTEF, the mRNA UCV Consortium, with strategic technology vendors and partners, is expected to be transformative for development and manufacturing of mRNA vaccines and medicines for COVID-19 and future pandemic preparedness.

Learn more: Scientific development of a pan-coronavirus vaccine and advantages of mRNA vaccines with LNP delivery mechanism