Patent ID: 9422330
Filing Date: 2016-08-23
CPC Classification: C07K

Claim Text:
1. A method of isolating a polypeptide of interest, the method comprising: a. introducing to a preparative reversed phase-high performance/pressure liquid chromatography (RP-HPLC) system a fluid mixture comprising the polypeptide of interest, the mixture being dissolved in a mobile phase, wherein the mobile phase has a pH value which is at least 1 unit from the pI value of the polypeptide of interest; b. adjusting the pH of the mobile phase to a pH value which is less than 1 unit from the pI value of the polypeptide of interest, wherein the adjustment in pH is done in a step-wise procedure or with a pH gradient; and c. eluting the polypeptide of interest to provide a purified composition thereof; wherein the polypeptide of interest is separated from at least one related impurity in the fluid mixture; wherein said related impurity is selected from: a glycosylated form of, a deamidated form of, a truncated form of, an extended form of, an incorrectly folded form of, an oxidized form of, a form with undesired glycosylation of, a form resulting from racemization of, a form lacking amino acids in an intra-peptide chain of, a form having extra amino acids in an intra-peptide chain of, and a form wherein an acylation has taken place on another residue than desired of, the polypeptide of interest; and wherein the polypeptide of interest is a Glucagon-Like Peptide-1 (GLP-1) selected from N-ε 26 -[2-(-2-[2-(2-[2-(2-[4-(17-Carboxyheptadecanoylamino)-4(s)-carboxybutyrylaminol]ethoxy)ethoxyl]acetylamino)ethoxyl]ethoxy)acetyl]-Aib8,Arg34-GLP-1(7-37); and Arg 34 , Lys 26 (N ε -(γ-Glu(N α -hexadecanoyl)))-GLP-1(7-37).