Claims for Patent: 10,273,448

Summary for Patent: 10,273,448

Title:	Medium containing uridine and N-acetyl-D-mannosamine
Abstract:	Provided are a novel medium for expressing glycoproteins by culturing cells and a method for producing glycoproteins by culturing cells in the medium. Further provided are a medium comprising uridine and N-acetyl-D-mannosamine for the use of expression of a glycoprotein by culturing cells and a method for producing glycoproteins by culturing cells in the medium.
Inventor(s):	Matev; Miroslav (Kobe, JP), Takahashi; Kenichi (Kobe, JP), Kakimoto; Shinji (Kobe, JP), Kotani; Ayaka (Kobe, JP)
Assignee:	JCR PHARMACEUTICALS CO., LTD. (Ashiya-shi, JP)
Application Number:	15/365,331
Patent Claims:	1. A cell culture medium comprising: uridine at a concentration of 0.5 to 10 mM; and N-acetyl-D-mannosamine at a concentration of 1 to 15 mM, wherein, when a recombinant glycoprotein is produced in said cell culture medium, the average number of sialic acid molecules per molecule of said recombinant glycoprotein is about 20% or greater than 20% compared to that produced in a cell culture medium lacking said uridine and said N-acetyl-D-mannosamine. 2. The medium according to claim 1, wherein the concentration of uridine is 1 to 8 mM, and the concentration of N-acetyl-D-mannosamine is 4 to 12 mM. 3. The medium according to claim 1, wherein the concentration of uridine is 2 to 5 mM and the concentration of N-acetyl-D-mannosamine is 5 to 10 mM. 4. The medium according to claim 1, wherein the concentration of uridine is about 3 mM and the concentration of N-acetyl-D-mannosamine is about 8 mM. 5. The medium according to claim 1, further comprising: L-alanyl-L-glutamine. 6. The medium according to claim 5, wherein the concentration of L-alanyl-L-glutamine is 0.5 to 5 mM. 7. The medium according to claim 5, wherein the concentration of L-alanyl-L-glutamine is 1 to 3 mM. 8. The medium according to claim 5, wherein the concentration of L-alanyl-L-glutamine is about 2 mM. 9. The medium according to claim 1, wherein the medium does not include serum. 10. A method of producing a glycoprotein, comprising: culturing a cell transformed with an exogenous DNA encoding the glycoprotein in the medium according to claim 1. 11. The method according to claim 10, wherein the exogenous DNA encoding the glycoprotein is incorporated into an expression vector such that the glycoprotein is expressed in a transformed cell. 12. The method according to claim 10, wherein the exogenous DNA encoding the glycoprotein is a human-derived DNA. 13. The method according to claim 10, wherein the cell is a mammalian cell. 14. The method according to claim 13, wherein the mammalian cell is a CHO cell. 15. The method according to claim 10, wherein the cell is selected from the group consisting of a mammalian cell, a plant cell, and an insect cell. 16. The method according to claim 13, wherein the exogenous DNA encoding the glycoprotein is incorporated into an expression vector such that the glycoprotein is expressed in a transformed cell. 17. The method according to claim 13, wherein the exogenous DNA encoding the glycoprotein is a human-derived DNA. 18. The method according to claim 13, further comprising: incubating the mammalian cell at a temperature of 36 to 37.degree. C.; and subsequently incubating the mammalian cell at a temperature of 30 to 35.degree. C. 19. The method according to claim 13, further comprising: incubating the mammalian cell at a temperature of 36 to 37.degree. C.; and subsequently incubating the mammalian cell at a temperature of 31 to 33.degree. C. 20. The method according to claim 13, further comprising: incubating the mammalian cell at a temperature of 36 to 37.degree. C.; and subsequently incubating the mammalian cell at a temperature of about 32.degree. C. 21. The method according to claim 10, wherein the glycoprotein is selected from the group consisting of a lysosomal enzyme, a blood coagulation factor, a lymphokine, erythropoietin, interferon, thrombomodulin, DNaseI, thyroid stimulating hormone, mouse antibody, humanized mouse antibody, human/mouse chimeric antibody, human antibody, PD-1, PD-1 ligand, and follicle stimulating hormone. 22. The method according to claim 10, wherein the glycoprotein is selected from the group consisting of .alpha.-galactosidase A, acid sphingomyelinase, lysosomal acid lipase, N-acetylgalactosamine-4-sulfatase, hexosaminidase, .alpha.-N-acetylgalactosaminidase, .alpha.-mannosidase, iduronate-2-sulfatase, glucocerebrosidase, galsulfase, .alpha.-L-iduronidase, sialidase, acid .alpha.-glucosidase, blood coagulation factor VII, blood coagulation factor VIII, blood coagulation factor IX, interleukin-6, granulocyte-colony stimulating factor, granulocyte macrophage colony-stimulating factor, and macrophage colony-stimulating factor. 23. The method according to claim 10, wherein the glycoprotein is erythropoietin. 24. The method for production according to claim 10, wherein the glycoprotein includes sialic acid in a glycan thereof. 25. The method for production according to claim 10, further comprising: collecting a culture after the culturing; and removing the mammalian cells from collected culture such that a culture supernatant including the glycoprotein is prepared.

Details for Patent 10,273,448

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Biomarin Pharmaceutical Inc.	NAGLAZYME	galsulfase	Injection	125117	05/31/2005		2034-05-31