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US 12,667,606 B2Granted
Formulations of protein molecules comprising iduronate 2-sulfatase
AssigneeDenali Therapeutics Inc.
InventorsDana Andersen, Adam Catherman, Tina Giese, Gunasekaran Kannan, Mihalis S. Kariolis, Cathal S. Mahon, Ankit Patel
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Abstract
Certain embodiments provide a pharmaceutical composition comprising: a protein molecule comprising an ERT enzyme-Fc fusion polypeptide and a modified Fc polypeptide; a buffer; an isotonicity agent; a surfactant; and a stabilizer; wherein the pH of the pharmaceutical composition is about 5.5 to 7.0, as well as methods of use thereof.
Claims37
A pharmaceutical composition comprising:
- a. (i) a protein molecule comprising:
- a first Fc polypeptide comprising the amino acid sequence of SEQ ID NO:42;
- and a fusion polypeptide comprising the amino acid sequence of SEQ ID NO:
- 40;
- and
- (ii) a protein molecule comprising:
- a first Fc polypeptide comprising the amino acid sequence of SEQ ID NO:42;
- and a fusion polypeptide comprising the amino acid sequence of SEQ ID NO:
- 39;
- b. a buffer;
- and
- c. a salt;
- wherein the pH of the pharmaceutical composition is about 5.5 to 7.0.
10 more elements
A pharmaceutical composition comprising:
- a. (i) a protein molecule comprising:
- a first Fc polypeptide comprising the amino acid sequence of SEQ ID NO:42;
- and a fusion polypeptide comprising the amino acid sequence of SEQ ID NO:
- 40;
- and
- (ii) a protein molecule comprising:
- a first Fc polypeptide comprising the amino acid sequence of SEQ ID NO:42;
- and a fusion polypeptide comprising the amino acid sequence of SEQ ID NO:
- 39;
- b. about 10-30 mM of sodium phosphate buffer;
- c. about 30-100 mM sodium chloride;
- d. about 0.4-0.7 mg/mL of a polysorbate surfactant;
- e. about 150-200 mM of sucrose;
- and
- f. about 5-25 mM methionine;
- wherein the pH of the pharmaceutical composition is 6.5±0.5.
13 more elements
Dependencies are inferred from the claim text.