➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Colorcon
Harvard Business School
Baxter
Moodys

Last Updated: August 7, 2020

DrugPatentWatch Database Preview

Claims for Patent: 8,034,906

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

Summary for Patent: 8,034,906
Title:Crystalline anti-hTNFalpha antibodies
Abstract: The present invention relates to a batch crystallization method for crystallizing an anti-hTNFalpha antibody which allows the production of said antibody on an industrial scale; antibody crystals as obtained according to said method; compositions containing said crystals as well as methods of use of said crystals and compositions.
Inventor(s): Borhani; David W. (Hartsdale, NY), Fraunhofer; Wolfgang (Newton, MA), Krause; Hans-Juergen (Gruenstadt, DE), Koenigsdorfer; Anette (Ilvesheim, DE), Winter; Gerhard (Penzberg, DE), Gottschalk; Stefan (Grunwald, DE)
Assignee: Abbott Biotechnology Ltd. (Hamilton, BM)
Application Number:11/977,677
Patent Claims:1. A crystal of an intact D2E7 (adalimumab) antibody, wherein said crystal has a needle morphology with a length of about 2-500 .mu.m and an l/d ratio of about 3 to 30.

2. The crystal of claim 1, wherein the antibody is non-glycosylated.

3. A composition comprising the crystal of claim 1.

4. The composition according to claim 3, wherein said composition has an antibody concentration greater than about 1 mg/ml.

5. A pharmaceutical composition comprising: (a) the crystal according to claim 1, and (b) at least one pharmaceutical excipient.

6. The pharmaceutical composition of claim 5, wherein said pharmaceutical formulation is provided as a solid, a semisolid, or a liquid formulation.

7. The pharmaceutical composition according to claim 6, wherein said pharmaceutical composition has an antibody concentration greater than about 200 mg/ml.

8. A pharmaceutical composition comprising: (a) the crystal according to claim 1, and (b) at least one pharmaceutical excipient which embeds or encapsulates the crystal.

9. The pharmaceutical composition according to claim 8, wherein said excipient comprises at least one polymeric carrier or at least one oil or lipid carrier.

10. The pharmaceutical composition according to claim 9, wherein said polymeric carrier is a polymer selected from one or more of the group consisting of poly(acrylic acid), poly(cyanoacrylates), poly(amino acids), poly(anhydrides), poly(depsipeptide), poly (esters), poly(lactic acid), poly(lactic-co-glycolic acid) or PLGA, poly([3-hydroxybutryate), poly (caprolactone), poly(dioxanone); poly(ethylene glycol), poly(hydroxypropyl)methacrylamide, poly(organo) phosphazene, poly(ortho esters), poly(vinyl alcohol), poly(vinylpyrrolidone), maleic anhydride alkyl vinyl ether copolymers, pluronic polyols, albumin, alginate, cellulose and cellulose derivatives, collagen, fibrin, gelatin, hyaluronic acid, oligosaccharides, glycaminoglycans, sulfated polysaccharides, and blends and copolymers thereof.

11. An injectable liquid composition comprising the crystal according to claim 1, wherein said composition has an antibody concentration in the range of about 10 to 400 mg/ml.

12. A crystal slurry comprising the crystal according to claim 1, wherein said slurry has an antibody concentration greater than about 100 mg/ml.

13. A composition comprising a crystal of a D2E7 (adalimumab) antibody, said composition obtainable by a batch crystallization method, wherein said crystal has a needle morphology with a length of about 2-500 .mu.m and an l/d ratio of about 3 to 30.

14. The composition of claim 13, wherein the antibody is non-glycosylated.

15. The composition according to claim 13, wherein said composition has an antibody concentration greater than about 1 mg/ml.

16. A pharmaceutical composition comprising: (a) the composition according to claim 13, and (b) at least one pharmaceutical excipient.

17. The pharmaceutical composition of claim 16, wherein said pharmaceutical formulation is provided as a solid, a semisolid, or a liquid formulation.

18. The pharmaceutical composition according to claim 16, wherein said pharmaceutical composition has an antibody concentration greater than about 200 mg/ml.

19. A pharmaceutical composition comprising: (a) the composition according to claim 13, and (b) at least one pharmaceutical excipient which embeds or encapsulates the crystal.

20. The pharmaceutical composition according to claim 19, wherein said excipient comprises at least one polymeric carrier or at least one oil or lipid carrier.

21. The pharmaceutical composition according to claim 20, wherein said polymeric carrier is a polymer selected from one or more of the group consisting of poly(acrylic acid), poly(cyanoacrylates), poly(amino acids), poly(anhydrides), poly(depsipeptide), poly (esters), poly(lactic acid), poly(lactic-co-glycolic acid) or PLGA, poly((3-hydroxybutryate), poly (caprolactone), poly(dioxanone); poly(ethylene glycol), poly(hydroxypropyl)methacrylamide, poly(organo) phosphazene, poly(ortho esters), poly(vinyl alcohol), poly(vinylpyrrolidone), maleic anhydride alkyl vinyl ether copolymers, pluronic polyols, albumin, alginate, cellulose and cellulose derivatives, collagen, fibrin, gelatin, hyaluronic acid, oligosaccharides, glycaminoglycans, sulfated polysaccharides, and blends and copolymers thereof.

22. A batch crystallization method for crystallizing an IgG human anti-hTNFalpha antibody, said method comprising (a) combining an aqueous solution of said antibody, an inorganic phosphate salt, and an acetate buffer to obtain an aqueous crystallization mixture, wherein the aqueous crystallization mixture has a pH about 3 to about 5, has an acetate buffer concentration of about 0M to about 0.5M, has an inorganic phosphate salt concentration of about 1M to about 6M, and has an antibody concentration of about 0.5 mg/ml to about 100 mg/ml; and (b) incubating said aqueous crystallization mixture at a temperature of about 4.degree. C. to 37.degree. C. until a crystal of said antibody is formed, wherein the antibody comprises a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 1, and a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 2, and wherein the crystal has a needle morphology with a length of about 2-500 .mu.m and an l/d ratio of about 3 to 30.

23. The crystallization method according to claim 22, wherein the antibody is D2E7 (adalimumab).

24. The crystallization method according to claim 22 or 23, further comprising the step of drying said crystal.

25. The crystallization method according to claim 22 or 23, further comprising the step of exchanging a crystallization mother liquor with a different buffer.

26. The crystallization method according to claim 22 or 23, wherein said method is performed in a batch volume in the range of about 1 ml to about 20,000 liters.

Details for Patent 8,034,906

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   Start Trial Abbott Biotechnology Ltd. (Hamilton, BM) 2026-10-27 RX search
Abbvie Inc HUMIRA adalimumab VIAL 125057 002 2002-12-31   Start Trial Abbott Biotechnology Ltd. (Hamilton, BM) 2026-10-27 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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

Serving leading biopharmaceutical companies globally:

Harvard Business School
Dow
Merck
Mallinckrodt
Medtronic
Moodys

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 verification 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.