METHODS FOR DIFFERENTIATING PLASMA-DERIVED PROTEIN FROM RECOMBINANT PROTEIN IN A SAMPLE

摘要

Disclosed is a method to quantitate the amount of plasma-derived protein (PdP) and recombinant protein (rP) in a sample from an individual, wherein the plasma-derived protein and recombinant protein are the same protein with different glycosylation patterns, said different glycosylation patterns giving rise to different degrees of lectin binding for the plasma-derived protein compared to the recombinant protein, wherein total protein (tP) in said sample is predetermined and equal to the amount of plasma-derived protein and recombinant protein (pdP+rP), said method comprising the steps of: (a) contacting the sample with a lectin composition and detecting protein binding to the lectin composition; and (b) calculating a difference between lectin binding for said sample from said individual and expected lectin binding for a second sample of equal volume having an amount of plasma-derived protein equal to total protein (tP), wherein the difference is proportional to the amount of recombinant protein in the sample from the individuals.