Production of a SARS-CoV-2 Spike Protein Vaccine Using the Baculovirus Expression Vector System

Various COVID-19 vaccines are currently in development, as the COVID-19 pandemic has created an unmet need for protection against the SARS-CoV-2 virus. While there are many different types of vaccines, we focused on developing one that would be safe, affordable, and quickly available for emergency use. A vaccine synthesized using recombinant proteins utilizes a reliable and well-studied technological platform, avoids the safety risks inherent to viral vectors, and provides a cost-effective, scalable method of production of antigen used to induce an immune response. Other vaccines on the market notably include Pfizer’s and Moderna’s mRNA based vaccines. Although these are widely used, there is still a large demand for an inexpensive yet safe and effective vaccine. Herein, we propose the production of 500 million doses of a recombinant spike protein-based COVID-19 vaccine in a quick time frame and cost-effective manner, using the baculovirus expression vector system (BEVS). Our upstream process involves a three-stage cellular scale-up from shake flasks to WAVE bioreactors to perfusion to production bioreactors, as well as an additional two-stage viral amplification from flasks to WAVE bioreactors. Our downstream process involves a six-stage protein recovery with depth filtration, his-tag chromatography, viral inactivation, ion-exchange chromatography, viral filtration, and diafiltration. We will be partnering with a contract manufacturing organization (CMO) for this project, as we do not have the time to quickly build a plant to get these vaccines out for emergency use. This arrangement makes this process highly profitable. Selling each dose for $16 yields net earnings near $2 billion and an extremely high IRR due to the lack of permanent and fixed costs other than our rental fee. The IRR for the CMO is estimated to be at least 16% with the NPV of the plant at $855,000 and an ROI of 18%.