Manufacturing the next generation of vaccines: non-egg based platform for influenza vaccine

This report explores the design of an influenza vaccine manufacturing facility using a non-egg based expression platform. The current standard procedure in flu vaccine production is to grow the virus in bird eggs. However, recently there is evidence that supports production by other expression platforms. The Sf9 insect cell is considered in this report. Facility design including cell culture media formulation through product storage for shipment and final formulation is considered based on the use of an existing facility. The new design also employs the use of disposable equipment such as bioreactors and purification unit operations. These disposables help reduce production time and are an economically viable option. Market trends are analyzed, and it is concluded that production capabilities for this proposed facility should be about 60 million doses per year to accommodate one third of the market and be able to account for potential epidemics. At this production, revenue is approximately $391 million per year. Capital costs are very low due to the use of the existing facility, and manufacturing costs are also very reasonable even with the use of disposable equipment. Based on a 10 year project lifetime, the NPV for the project is approximately $460 million. The project is economically robust when considering various factors such as fluctuating dosage selling price, dosage demand, and manufacturing costs. A major concern for the profitability of this project is if the market will accept large quantities of vaccine produced by new methods that are not historically tested and proven to work. More research should conducted to determine how the market will react to such changes. The next step in the design process is to conduct laboratory and pilot-scale tests to determine more exact cell and virus growth curves for the seed train and the bioreactors. Once this information is collected, more precise designs can be formulated. Based on the considerations in this report, the production of influenza vaccine using the Sf9 expression platform is viable both economically and in its ability to meet market demands in a timely manner. Companies on the leading edge of this development will have a great deal to gain