Methods for differentiating plasma-derived protein from recombinant protein in a sample
AssigneesBaxter International Inc., Baxter Healthcare S.A.
InventorsAlfred Weber, Peter Turecek, Hans-Peter Schwarz
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Abstract
The present invention relates, in general, to methods for detecting and quantitating plasma-derived protein and recombinant protein in a sample based on the difference in protein glycosylation, when the plasma protein and the recombinant protein are essentially the same protein.
Claims14
A method of determining the amount of plasma-derived protein in a sample comprising plasma-derived and recombinant forms of the protein comprising,
- contacting the sample with a composition comprising a lectin;
- detecting amount of binding of the lectin to the plasma-derived protein in said sample;
- and
- comparing the amount of binding between the lectin and the plasma-derived protein in the sample to a lectin:protein binding curve with increasing amounts of plasma derived protein to determine the amount of plasma-derived protein in the sample, 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.
A kit for quantitating levels of plasma derived protein and recombinant protein in a sample, wherein the plasma-derived protein and the recombinant protein are the same protein with different glycosylation patterns, the kit comprising
- a protein binding agent;
- a composition comprising a lectin specific for a carbohydrate on the plasma-derived protein and not the recombinant protein and a detectable label, wherein the plasma-derived protein and the recombinant protein have different glycosylation patterns and contacting the proteins with the lectin composition gives rise to different degrees of lectin binding;
- and
- a protein standard comprising known concentrations of plasma-derived protein that is bound by the lectin composition, wherein the protein standard is used to make a calibration curve of lectin binding to the protein standard.
Dependencies are inferred from the claim text.