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Last Updated: March 29, 2024

Claims for Patent: 10,532,098


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Summary for Patent: 10,532,098
Title:Stabilized aqueous antibody compositions
Abstract: The present invention provides an aqueous solution comprising an antibody protein at a concentration of at least about 10 mg/mL and an oligomer of ethyleneimine, wherein the number of repeating units of ethyleneimine (n) in the oligomer is in the range n=2-12.
Inventor(s): Jezek; Jan (Saffron Walden, GB), Casy; Guy (Saffron Walden, GB), Derham; Barry Kingston (Saffron Walden, GB), Royle; Nikki (Saffron Walden, GB)
Assignee: Arecor Limited (Cambridge, GB)
Application Number:14/375,257
Patent Claims:1. An aqueous solution comprising an antibody protein at a concentration of at least about 10 mg/mL and an oligomer of ethyleneimine, wherein (a) the aqueous solution is substantially free of a buffer with a pKa within 1 unit of the pH of the solution, (b) the antibody is (i) trastuzumab, (ii) rituximab, (iii) infliximab, (iv) a fusion protein comprising an active protein domain fused to one or more immunoglobulin Fc fragments, or (v) certolizumab pegol; and (c) the number of repeating units of ethyleneimine (n) in the oligomer is in the range consisting of 2 to 12.

2. The aqueous solution of claim 1, wherein the number of repeating units of ethyleneimine (n) is 3.

3. The aqueous solution of claim 1, wherein the number of repeating units of ethyleneimine (n) in the oligomer is in the range consisting of n=3 to 5.

4. The aqueous solution of claim 1, wherein the oligomer of ethyleneimine is derivatised with one or more PEG or mPEG groups.

5. The aqueous solution of claim 4, wherein the oligomer of ethyleneimine is derivatised via an optional bridging group, wherein said bridging group is selected from the group consisting of carbonyl, amide, carbamate, urea and alkylene.

6. The aqueous solution of claim 1, wherein the oligomer of ethyleneimine is selected from the group consisting of diethylenetriamine, triethylenetetramine, tetraethylenepentamine and pentaethylenehexamine.

7. The aqueous solution of claim 1, wherein 80 to 100% of the basic nitrogen centres of the oligomer of ethyleneimine are protonated.

8. The aqueous solution or method of claim 1, wherein the oligomer of ethyleneimine is present at a concentration of about 0.01 mg/mL to about 10 mg/mL.

9. The aqueous solution of claim 1, wherein the antibody protein is a therapeutic agent.

10. The aqueous solution of claim 1, wherein the antibody protein is trastuzumab, rituximab or infliximab.

11. The aqueous solution of claim 1, wherein the antibody protein is a fusion protein comprising an active protein domain fused to one or more immunoglobulin Fc fragments.

12. The aqueous solution of claim 11, wherein the antibody protein is etanercept, abatacept or belatacept.

13. The aqueous solution of claim 1, wherein the antibody protein is certolizumab pegol.

14. The aqueous solution of claim 1, wherein the antibody protein concentration is between about 25 mg/mL and about 300 mg/mL.

15. The aqueous solution of claim 1, wherein the antibody protein concentration is greater than 50 mg/mL.

16. The aqueous solution or method of claim 1, wherein the weight ratio (wt/wt) of antibody protein to the oligomer of ethyleneimine is at least 10.

17. The aqueous solution of claim 1, wherein the pI of the antibody protein is at least 7.

18. The aqueous solution of claim 17, wherein the pI of the antibody protein is in the range of 7 to 10.

19. A packaged pharmaceutical composition suitable for administration to a subject in need thereof, comprising the aqueous solution of claim 1.

20. The aqueous solution of claim 1, wherein the oligomer of ethyleneimine is triethylenetetramine.

21. The aqueous solution of claim 1, wherein the pH of the solution is in the range 5 to 7.5.

22. The aqueous solution of claim 10, wherein the pI of the antibody protein is in the range of 7 to 10.

23. The aqueous solution of claim 11, wherein the pI of the antibody protein is in the range of 7 to 10.

24. The aqueous solution of claim 1, wherein the number of repeating units of ethyleneimine (n) in the oligomer is in the range consisting of 6 to 12.

25. The aqueous solution of claim 1, wherein the number of repeating units of ethyleneimine (n) is 4.

26. The aqueous solution of claim 1, wherein the number of repeating units of ethyleneimine (n) is 5.

Details for Patent 10,532,098

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 11/26/1997 ⤷  Try a Trial 2040-01-24
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 08/24/1998 ⤷  Try a Trial 2040-01-24
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 09/25/1998 ⤷  Try a Trial 2040-01-24
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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