Post-Preclinical Process Development for the Production of Recombinant Vaccine and Inactive Virus Vaccine Against SARS-CoV-2 Virus

The coronavirus disease (COVID-19) has spread all over the world in a short time and has been declared a pandemic. The SARS-CoV-2 virus that causes COVID-19 disease has posed a major public health threat that requires effective therapeutics and vaccination strategies. It is necessary to develop, test, and manufacture a safe and effective vaccine as a longer-term solution to prevent morbidity and mortality. COVID-19 vaccine candidates include protein-based vaccines containing target antigens in vitro, such as inactivated virus vaccines, virus-like particles, and protein subunit vaccines; viral vector vaccines, DNA and mRNA vaccines, typically live-attenuated virus vaccines.

According to the researches, the global vaccine production capacity is 2-4 billion doses per year, and the amount of vaccine against COVID-19 that will be sufficient for the entire world population will only be produced in 2023-2024. For this reason, industrial-scale production of developed vaccine candidates is as important as R&D and preclinical studies for vaccine development.

Within the scope of the project, it is aimed to develop modern and effective processes for the production of inactivated virus vaccine and recombinant virus vaccine against SARS-CoV-2 virus with high efficiency. In line with this goal, optimization strategies of upstream and downstream processes will be developed in the transition to a large scale of vaccines produced and purified in R&D stages. Process optimization and critical process parameters for scale-up will be studied in detail within the scope of this project. Following the bioreactor inoculation and production process, cell culture performance will be evaluated using analytical techniques. In addition, detailed cell culture processes will be carried out, medium optimization based on cell metabolism and feeding strategy optimization will be provided within the scope of this project.

In this project, necessary processes will be developed in scale-up studies for the mass production of the first domestic inactivated COVID-19 vaccine, which has not yet been mass-produced but only for sufficient doses for clinical studies. In addition, the pilot and large-scale production of the recombinant protein-based COVID-19 vaccine, whose preclinical testing processes have been completed but have not yet been produced for the clinical-stage, will be carried out for the first time within the scope of this project. The other unique aspect of the project is that the protein used in the vaccine formulation is a completely new vaccine candidate, from the transfection method to the final formulation, and that pilot and large-scale production processes will be developed.

The methods and methods to be applied for the development and production of vaccines within the scope of the project will ensure that the know-how required for domestic vaccine production, which is one of the strategic issues of our country, will spread in our country, ensure the training of expert researchers in the field, and contribute to the trained manpower that our country needs the most. The experience and knowledge gained will also contribute to the creation of new projects for the development and production of many biotechnological products (fast and effective vaccines against new pathogens that may arise in the future, diagnostic kits, hyper-immune serums, etc.).