The production of heterologous plasma proteins.

Plasma proteins have been early commercial targets for heterologous expression in cell systems. Much of the impetus for the design and implementation of such processes has come from the desire to supply a market with products that do not rely on the fractionation of donated plasma. The production of recombinant plasma proteins would avoid the hazards of blood-derived products, the most notable of which is viral contamination. Although, when processed correctly, blood-derived products are virtually free from transmitting viral infections, a perceived risk of contamination exists for the manufacturer, user and patient. These risks have been well-documented in the press over the past decade. In this article, the production of human serum albumin (HSA) is used to illustrate the challenge of manufacturing a nature-identical plasma protein from a heterologous source.