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US 12,644,108 B2Granted
Process intermediate in the purification of collagenase drug substances
AssigneeEndo Operations Limited
InventorsChristine A. Sheaffer, Michael Berbaum, John Hanna, Jason Dziadosz, Daniel Shanafelt
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Abstract
The present invention relates to the fields of collagenase production and collagenase products, and particularly to improving the reproducibility, purity, and stability of collagenase I and collagenase II compositions, where the compositions are pure to at least 95% by area as measured by reverse phase high pressure liquid chromatography (RP-HPLC) and essentially free of neutral protease.
Claims11
A composition for purification of a collagenase, the composition comprising:
- a collagenase derived from Clostridium histolyticum;
- a metalloprotease derived from Clostridium histolyticum, wherein the metalloprotease is not a collagenase enzyme;
- ammonium sulfate;
- a zinc content of less than about 80 ppm;
- and
- a nickel content of less than about 2.0 ppm.
3 more elements
Dependencies are inferred from the claim text.