Enzymatic activity assays for glucocerebrosidase
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United States of America Patent
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Sep 1, 2020
Grant Date -
Feb 22, 2018
app pub date -
Dec 16, 2015
filing date -
Dec 18, 2014
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Abstract
The present invention provides, among other things, methods and compositions for determining enzyme kinetic parameters (e.g., Vmax, Km, and specific activity, etc.) indicative of clinically relevant properties of glucocerebrosidase using a physiologically relevant substrate, in particular, a substrate that is representative of substrates that typically accumulate in patients suffering from Gaucher disease such as glucosylceramide. Thus, the present invention is particularly useful to measure a kinetic parameter relating to the activity of glucocerebrosidase in a drug substance, drug product, and stability sample for enzyme replacement therapy.
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