Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Chubb
Fish and Richardson
AstraZeneca
Express Scripts
Johnson and Johnson

Generated: August 22, 2019

DrugPatentWatch Database Preview

Claims for Patent: 9,499,614

  Try a free trial


See Plans and Pricing

« Back to Dashboard

Summary for Patent: 9,499,614
Title:Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides
Abstract: The present invention relates to the field of protein production, and in particular to methods and compositions for modulating glycosylation of proteins expressed in host cells.
Inventor(s): Hossler; Patrick (Westborough, MA), McDermott; Sean (Warwick, RI), Racicot; Christopher (Auburn, MA), Correia; Ivan (Winchester, MA)
Assignee: AbbVie Inc. (North Chicago, IL)
Application Number:14/209,821
Patent Claims:1. A method of producing a composition comprising an immunoglobulin with an increased level of mannosylated N-glycans and/or a decreased level of fucosylated N-glycans, wherein the immunoglobulin comprises a light chain variable region of SEQ ID NO:1 and a heavy chain variable region of SEQ ID NO:2, said method comprising: culturing a mammalian host cell expressing said immunoglobulin in cell culture media supplemented with 5 mM-100 mM sucrose, thereby producing said composition comprising said immunoglobulin with an increased level of mannosylated N-glycans and/or a decreased level of fucosylated N-glycans as compared to a control, wherein said control is a composition comprising the immunoglobulin produced by culturing the mammalian host cell expressing said immunoglobulin in cell culture media which is not supplemented with sucrose.

2. The method of claim 1, further comprising purifying said composition comprising said immunoglobulin with a modulated glycosylation profile.

3. The method of claim 1, wherein the immunoglobulin is an antibody or antigen-binding portion thereof.

4. The method of claim 1, wherein the immunoglobulin is adalimumab, or an antigen binding fragment thereof.

5. The method of claim 1, wherein the immunoglobulin is a dual variable domain immunoglobulin (DVD-Ig).

6. The method of claim 1, wherein the immunoglobulin is selected from the group consisting of a TVD-IG, a half-body and a RAB.

7. The method of claim 1, further comprising supplementing the cell culture media with tagatose.

8. The method of claim 7, wherein the cell culture media is supplemented with a sufficient amount of tagatose to achieve a tagatose concentration selected from the group consisting of about 1 mM, about 5 mM, about 7 mM, about 10 mM, about 20 mM, about 30 mM, about 40 mM, about 50 mM, about 60 mM, about 70 mM, about 80 mM, about 90 mM and about 100 mM.

9. The method of claim 8, wherein the tagatose concentration is 30 mM.

10. The method of claim 1 wherein the cell culture media is supplemented with a sufficient amount of sucrose to achieve a sucrose concentration selected from the group consisting of about 5 mM, about 7 mM, about 10 mM, about 20 mM, about 30 mM, about 40 mM, about 50 mM, about 60 mM, about 70 mM, about 80 mM, about 90 mM and about 100 mM.

11. The method of claim 10, wherein the sucrose concentration is 30 mM.

12. The method of claim 1, wherein the method produces a composition comprising an immunoglobulin with an overall increase in the mannosylated N-glycan level.

13. The method of claim 12, wherein the increase in the mannosylation level comprises an increase in the level of a high mannose N-glycan oligosaccharide selected from the group consisting of Man 5 glycan, Man 6 glycan, Man 7 glycan and Man 8 glycan.

14. The method of claim 1, wherein the method produces a composition comprising an immunoglobulin with an overall decrease in the fucosylated N-glycan level.

15. The method of claim 14, wherein the overall decrease in the fucosylation level comprises an increase in NGA2F-GlcNAc and NA1F-GlcNAc and a decrease in the level of NGA2F, and NA1F in said immunoglobulin.

16. The method of claim 1, wherein the decrease in the fucosylation level comprises a decrease in the level of NGA2F, and/or NA1F in said immunoglobulin.

17. The method of claim 1, wherein said host cell is a CHO cell.

18. A method of producing a composition comprising adalimumab with a modulated glycosylation profile, said method comprising: culturing a mammalian host cell expressing adalimumab in cell culture media supplemented with 5 mM-100 mM sucrose, thereby producing said composition comprising adalimumab with an increased level of mannosylated N-glycans and/or a decreased level of fucosylated N-glycans as compared to a control, wherein said control is a composition comprising adalimumab produced by culturing the mammalian host cell expressing adalimumab in cell culture media which is not supplemented with sucrose.

19. A method of producing a composition comprising an antibody, or antigen binding fragment thereof, with a modulated glycosylation profile, wherein the antibody or antigen-binding portion thereof comprises a light chain variable region of SEQ ID NO:1 and a heavy chain variable region of SEQ ID NO:2, said method comprising: culturing a mammalian host cell expressing said antibody, or antigen binding fragment thereof, in cell culture media supplemented with 5 mM-100 mM sucrose, thereby producing said composition comprising said antibody, or antigen binding fragment thereof, with an overall increase in the level of mannosylated N-glycans and an overall decrease in the level of fucosylated N-glycans as compared to a control, wherein said control is a composition comprising the antibody, or antigen binding fragment thereof, produced by culturing the mammalian host cell expressing said antibody, or antigen binding fragment thereof, in cell culture media which is not supplemented with sucrose.

20. The method of claim 19, wherein the antibody is adalimumab, or antigen binding fragment thereof.

21. A method of producing a composition comprising an antibody, or antigen binding fragment thereof, with a modulated glycosylation profile, wherein the antibody or antigen-binding portion thereof comprises a light chain variable region of SEQ ID NO:1 and a heavy chain variable region of SEQ ID NO:2, said method comprising: culturing a mammalian host cell expressing said antibody, or antigen binding fragment thereof, in cell culture media supplemented with 5 mM-100 mM sucrose, thereby producing said composition comprising said antibody, or antigen binding fragment thereof, with an increase in antibody-dependent cellular cytotoxicity (ADCC) response as compared to a control, wherein said control is a composition comprising the antibody, or antigen binding fragment thereof, produced by culturing the mammalian host cell expressing said antibody, or antigen binding fragment thereof, in cell culture media which is not supplemented with sucrose.

22. The method of claim 21, wherein the antibody is adalimumab, or antigen binding fragment thereof.

Details for Patent 9,499,614

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Abbvie Inc HUMIRA adalimumab SYRINGE 125057 001 2002-12-31 ➤ Sign Up AbbVie Inc. (North Chicago, IL) 2033-03-14 RX search
Abbvie Inc HUMIRA adalimumab VIAL 125057 002 2002-12-31 ➤ Sign Up AbbVie Inc. (North Chicago, IL) 2033-03-14 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

Subscribe to access the full database, or try a Free Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
McKesson
Baxter
Express Scripts
Citi
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.