2019 Student Design Composition: Manufacturing facility for a biopharmaceutical: Monoclonal antibody

Abstract

The biopharmaceutical facility for the production of monoclonal antibodies (MAbs) in this document was prompted by the 2019 AIChE Student Design Competition and follows all guidelines and rules contained within it. This design was created using SuperPro software and was frequently checked with simple mass balances to ensure the validity of the process. The proposed design to produce monoclonal antibodies involves the replication of Chinese Hamster Ovary (CHO) cells that are a “host” cell to the desired MAb. It is a “flexible” facility that is able to produce a wide range of MAbs that vary in concentration from 1-2 g/L titers to 5-10 g/L titers. All risks associated with this process have been carefully identified and mitigated through inherently safer design as well as active and passive safety measures. Our final design is able to run 21 batches in a year to produce 1307 kg per year.

The maximum temperature and pressure of the process are 37°C and 10 bar, respectively, though most of the process operates under ambient temperatures and pressures. The material of construction for the process equipment is stainless steel because of its resistance to corrosion and sterile. Inherently safer conditions were considered such simplification of the equipment and chemicals used in the process.

The total capital expenditures will cost $85.7 million and includes all process equipment and a building to house the equipment on the prepared existing site. Starting in the first full year of production, operating costs will be $8.7 million per year, and the project life span was set to be 25 years. The process’s capital and operating costs will be offset by the revenue which was calculated to be $16.0 billion per year.

The economic evaluation of our design resulted in a net present value of $65.7 billion, discounted cash flow rate of return of 5956%, and a payback period of 54 days. Our process is most sensitive to the selling price of our product, but given the fact that the process has a positive NPV of $52.5 billion with a 20% decrease in selling price and the historical consistency of the selling prices from major pharmaceutical companies, we are confident with the economic attractiveness of our project. Based upon these economic analyses, it has been concluded that this is a desirable and economically attractive project that we recommend moving into the detailed design stage and eventual construction.