Patent ID: 7163802
Filing Date: 2007-01-16
Classification: A61K,A61L,C07K,G01N,Y10T

Abstract:
1. In a process for obtaining a pharmaceutical product containing a mixture of polypeptides, each of which consists essentially of alanine, glutamic acid, tyrosine and lysine, wherein the mixture has an average molecular weight between 2000 and 40,000 Daltons and in the mixture the molar fraction of alanine is 0.38 to 0.5, of glutamic acid is 0.13 to 0.15, of tyrosine is 0.08 to 0.10 and of lysine is 0.3 to 0.4 and wherein during the process a batch of a mixture of polypeptides, each of which consists essentially of alanine, glutamic acid, tyrosine and lysine, is tested using a gel permeation chromatography column to determine whether the mixture has an average molecular weight between 2000 and 40,000 Daltons for inclusion in the pharmaceutical product, the improvement comprising calibrating the gel permeation chromatography column by subjecting a plurality of molecular weight markers, each of which is a polypeptide consisting essentially of alanine, glutamic acid, tyrosine and lysine and having a predetermined amino acid sequence, to chromatography on the column to establish a relationship between retention time on the column and molecular weight said relationship being used to determine average molecular weight of the mixture of polypeptides.