Chemistry: analytical and immunological testing – Peptide – protein or amino acid – Glycoproteins
Patent
1995-06-06
1996-10-22
Snay, Jeffrey
Chemistry: analytical and immunological testing
Peptide, protein or amino acid
Glycoproteins
436161, 436174, 530399, 530417, G01N 3006
Patent
active
055676200
ABSTRACT:
Described are methods for determining the potency of somatotropins. The level of biologically active bovine somatotropin protein in a bovine somatotropin sample is measured by size exclusion HPLC employing as the stationary phase a hydrophilic porous gel having an average particle diameter of about 5 .mu.m to about 15 .mu.m and the a mobile phase a buffered aqueous solution which is non-denaturing to the bovine somatotropin sample. The potency of the bovine somatotropin sample is determined based upon the level of biologically active bovine somatotropin protein so measured. In other embodiments, somatotropin is provided dissolved in a first buffer solution, and then chromatographed in a mobile phase comprised of a second buffer solution having a pH lower than the first buffer solution, to achieve an effective separation of biologically active protein from biologically-inactive large non-covalent soluble aggregates. The methods provide expedient, precise and accurate measures of the potency of somatotropin samples.
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Seaman, W. J. et al., "The lack of a growth-promoting effect of orally administered bovine somatotropin in the rat body-weight gain bioassay", Chemical Abstracts, vol. 108, No. 13, 106843r (1988).
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Eli Lilly and Company
Snay Jeffrey
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