Overview of the stability and handling of recombinant protein drugs.

Recombinant protein products have now been added to the inventory of parenteral drugs, and because of their newness, there exists a certain mystique about how they need to be handled. This article describes how the manufacturer determines both the shelf life and the proper preparation procedures for administering these new drugs. It will be shown that some recombinant protein drugs have comparable shelf lives to other parenteral drugs on the market. Also, it will be shown that, as for any parenteral drug, the manufacturer's recommended procedure for handling and administration of a recombinant protein drug should be followed.