Human Tissue Plasminogen Activator

Tissue plasminogen activator (tPA) has long been considered "the flagship product" of the biotechnology industry. This protein is a popular treatment for heart attacks, coronary heart disease, and stroke. Genentech has held a patent for the development of tPA-producing cells and sold it for approximately $2,000 per 100-mg dose. Within the next few years this patent will expire and the opportunity will exist to produce a generic form of tPA at a fraction of the cost. This design report describes a plant that can manufacture this recombinant protein without spending $500 MM on research and development costs. A cheap, generic form of tPA can acquire a large share of the current $300 MM tPA market. The FDA has recently prohibited the sale Abbott Laboratories' thrombolytic drug, urokinase. The only other thrombolytic medication available is streptokinase (SK); while it is much cheaper, SK causes more severe side effects and is somewhat less effective than tPA. It is therefore likely that the market for a generic tPA will expand as the price decreases. For this reason we have designed our plant to produce approximately 80 kg per year. Plant calculations were completed by hand and with the use of the SuperPro Designer program (for the Separation Section). Costing was completed using the economic spreadsheet created by Holger Nickisch. Purchase costs were obtained as company quotes or estimates from the design consultants. Our pharmaceutical plant has an investor's rate of return of 59.7% based on a total capital investment of $104 MM. Given the profitability of this process we highly recommend construction of this plant.