Patent ID: 6632800
Filing Date: 2003-10-14
Classification: C07K

Abstract:
A method of monitoring the production of a therapeutic polypeptide in a patient, said method comprising:(a) administering to said patient a nucleic acid construct encoding a therapeutic polypeptide and a marker polypeptide, wherein said marker polypeptide is releasable from a cell of said patient into an extracellular body fluid of said patient, wherein expression of said therapeutic polypeptide is regulated by a first promoter and expression of said marker polypeptide is regulated by a second promoter; and (b) detecting the presence or absence of said marker polypeptide above background in a sample of said extracellular body fluid, wherein the presence of said marker polypeptide above background in said sample is an indication that said therapeutic polypeptide is produced from said nucleic acid construct.