Patent: 10,760,112
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Summary for Patent: 10,760,112
Title: | Enzymatic activity assays for glucocerebrosidase |
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. |
Inventor(s): | Bernhardt; Peter (Lexington, MA), Yen; Chen-Chung Willy (Lexington, MA), Chhajlani; Vijay (Arlington, MA) |
Assignee: | Shire Human Genetic Therapies, Inc. (Lexington, MA) |
Application Number: | 15/537,296 |
Patent Claims: | see list of patent claims |
Details for Patent 10,760,112
Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
---|---|---|---|---|---|---|---|
Takeda Pharmaceuticals U.s.a., Inc. | VPRIV | velaglucerase alfa | For Injection | 022575 | 02/26/2010 | ⤷ Try a Trial | 2034-12-18 |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |