Non-denaturing potency assay for bovine somatotropin

G - Physics – 01 – N

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Details

G01N 30/02 (2006.01) C07K 14/61 (2006.01) G01N 33/483 (2006.01) G01N 33/68 (2006.01) G01N 33/74 (2006.01) G01N 30/34 (2006.01) G01N 30/52 (2006.01) G01N 30/88 (2006.01)

Patent

CA 2154794

Described is a method for determining the potency of bovine somatrotopin. The level of biologically active bovine somatotropin protein in the bovine somatotropin sample is measured by size exclusion HPLC employing as the stationary phase a hydrophilic porous polymer gel having an average particle diameter of about 5 µm to about 15 µm and as a mobile phase a buffered aqueous solution having a pH of about 8 to about 12 and which is non- denaturing to the boving somatotropin sample. The potency of the bovine somatotropin sample is determined based upon the level of biologically active bovine somatotropin protein so measured. The method provides an expedient, precise and accurate measure of the potency of a bST sample.

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