Production of Recombinant Therapeutic Proteins in the Milk of Transgenic Animals

Transgenic milk production offers a cost-effective system for the manufacturing of large amounts of complex proteins. Specifically, commercialization is near for recombinant human antithrombin (rhAT) expressed in transgenic dairy goats. The product received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicine Agency.

This article reviews the reasons why transgenic milk is a cost-effective system. Also reviewed is the earlier research on targeting heterologous proteins to the mammary glands of many different animals. The final section describes the process by which goats express rhAT in their milk at approximately 2 g/L. The human AT purified from milk is structurally indistinguishable from human plasma–derived AT with the exception of carbohydrates. Clinical studies are ongoing on the prevention of deep-vein thrombosis.

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Author(s): 
Yann Echelard , Carol A. Ziomek , Harry M. Meade.
Journal: 
BioPharm International, August 2006.