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Last Updated: October 22, 2019

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Claims for Patent: 8,883,146

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Summary for Patent: 8,883,146
Title:Protein formulations and methods of making same
Abstract: The invention provides an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality.
Inventor(s): Fraunhofer; Wolfgang (Gurnee, IL), Bartl; Annika (Ludwigshafen, DE), Krause; Hans-Juergen (Biblis, DE), Tschoepe; Markus (Hessheim, DE), Kaleta; Katharina (Ludwigshafen, DE)
Assignee: AbbVie Inc. (North Chicago, IL)
Application Number:13/774,735
Patent Claims:1. An aqueous formulation comprising an antibody, or antigen-binding fragment thereof, at a concentration of at least 50 mg/ml, a non-ionizable excipient, a buffer, and water, wherein the formulation has a conductivity of less than about 2.5 mS/cm, and the antibody, or antigen-binding fragment thereof, has a molecular weight (Mw) greater than about 47 kDa.

2. The formulation of claim 1, wherein the antibody, or antigen-binding fragment thereof, is selected from the group consisting of a chimeric antibody, a human antibody, a humanized antibody, and a domain antibody (dAb).

3. The formulation of claim 1, wherein the antibody, or antigen-binding fragment thereof, is an anti-tumor necrosis factor alpha (TNF.alpha.) antibody or an anti-interleukin-12 (IL-12) antibody.

4. The formulation of claim 1, wherein the antibody, or antigen-binding fragment thereof, is selected from the group consisting of adalimumab, alemtuzumab, Arcitumomab, cetuximab, trastuzumab, imciromab pentetate, capromab pendetide, infliximab, abciximab, rituximab, basiliximab, palivizumab, nofetumomab, omalizumab, daclizumab, ibritumomab tiuxetan, muromonab-CD3, edrecolomab, gemtuzumab ozogamicin, golimumab, certolizumab pegol, eculizumab, ustekinumab, panitumumab, tositumomab and I131 tositumomab, and bevacizumab.

5. The formulation of claim 1, wherein the concentration of the antibody, or antigen-binding fragment thereof, is 50 to 200 mg/ml.

6. The formulation of claim 1, wherein the non-ionizable excipient is a sugar or a polysorbate.

7. A device comprising the formulation of claim 1.

8. An article of manufacture comprising the device of claim 7.

9. An aqueous formulation comprising an antibody, or antigen-binding fragment thereof, at a concentration of at least 50 mg/ml, a non-ionizable excipient, a buffer, and water, wherein the formulation has a conductivity of less than about 2.5 mS/cm, wherein the antibody, or antigen-binding fragment thereof, has a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO:5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 7, and a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO:8.

10. The formulation of claim 9, wherein the antibody, or antigen-binding portion thereof, has an LCVR comprising the amino acid sequence set forth in SEQ ID NO: 1, and an HCVR comprising the amino acid sequence set forth in SEQ ID NO: 2.

11. The formulation of claim 10, wherein the antibody, or antigen-binding portion thereof, is adalimumab.

12. The formulation of claim 9, wherein the non-ionizable excipient is selected from the group consisting of a sugar or a polysorbate.

13. A method of preparing an aqueous formulation of an antibody, or antigen-binding fragment thereof, at a concentration of at least 50 mg/ml, a non-ionizable excipient, and a buffer, the method comprising: a) providing the antibody, or antigen-binding fragment thereof, in a first solution; b) subjecting the first solution to diafiltration using water as a diafiltration medium until at least a five-fold volume exchange with the water has been achieved to thereby prepare a diafiltered antibody solution; c) concentrating the diafiltered antibody solution and d) adding a non-ionizable excipient and a buffer to the concentrated diafiltered antibody solution, thereby preparing the aqueous formulation of the antibody, or antigen-binding fragment thereof, at a concentration of at least 50 mg/ml, a non-ionizable excipient, and a buffer wherein the antibody, or antigen-binding fragment thereof, has a molecular weight (Mw) greater than about 47 kDa.

14. A method of preparing an aqueous formulation comprising an antibody, or antigen-binding fragment thereof, at a concentration of at least 50 mg/ml, a non-ionizable excipient, and a buffer and water, the method comprising: a) providing the antibody, or antigen-binding fragment thereof, in a first solution; b) subjecting the first solution to diafiltration using water as a diafiltration medium until at least a five-fold volume exchange with the water has been achieved, to prepare a second solution; and c) adding a non-ionizable excipient and a buffer to the second solution, thereby preparing the aqueous formulation, wherein the antibody, or antigen-binding fragment thereof, has a molecular weight (Mw) greater than about 47 kDa.

15. The method of claim 14 or 13, wherein the antibody, antibody, or antigen-binding fragment thereof, is selected from the group consisting of a chimeric antibody, a human antibody, a humanized antibody, and a domain antibody (dAb).

16. The method of claim 14 or 13, wherein the antibody, or antigen-binding fragment thereof, is an anti-tumor necrosis factor alpha (TNF.alpha.) antibody or an anti-interleukin-12 (IL-12) antibody.

17. The method of claim 14 or 13, wherein the antibody, or antigen-binding fragment thereof, is selected from the group consisting of adalimumab, alemtuzumab, Arcitumomab, cetuximab, trastuzumab, imciromab pentetate, capromab pendetide, infliximab, abciximab, rituximab, basiliximab, palivizumab, nofetumomab, omalizumab, daclizumab, ibritumomab tiuxetan, muromonab-CD3, edrecolomab, gemtuzumab ozogamicin, golimumab, certolizumab pegol, eculizumab, ustekinumab, panitumumab, tositumomab and I131 tositumomab, and bevacizumab.

18. The method of claim 14 or 15, wherein the non-ionizable excipient is a sugar or a polysorbate.

Details for Patent 8,883,146

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Centocor Inc REOPRO abciximab INJECTABLE; INJECTION 103575 001 1994-12-22   Start Trial AbbVie Inc. (North Chicago, IL) 2027-11-30 RX search
Cytogen PROSTASCINT capromab pendetide VIAL; INTRAVENOUS 103608 001 1996-10-28   Start Trial AbbVie Inc. (North Chicago, IL) 2027-11-30 RX search
Centocor Inc MYOSCINT imciromab pentetate VIAL 103634 001 1996-07-03   Start Trial AbbVie Inc. (North Chicago, IL) 2027-11-30 DISCN search
Genentech RITUXAN rituximab VIAL 103705 001 1997-11-26   Start Trial AbbVie Inc. (North Chicago, IL) 2027-11-30 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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