Large Scale Production of Rh-Albumin Expressed in the Milk of Transgenic Cattle — An Economic and Technical Challenge

Abstract

Albumin from plasma fractionation is generally considered to be a safe and effective product. Nevertheless, a growing number of factors makes recombinant albumin manufacture increasingly attractive, i.e. the perceived risk of viral contamination in serum albumin, likelihood of reduced availability of recovered plasma in the future, and price. As a result of production technology evaluation, the expression of human albumin in the milk of transgenic cows has been identified as the most promising approach. A major challenge for this project is the fact that the production of pharmaceutical proteins on the scale of many tons, essentially free of any impurities at the price level of a commodity has not been achieved in recombinant biotechnology so far. In collaboration with Genzyme Transgenics Corp. (Framingham) project activities were initiated in February 1997.