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Last Updated: May 10, 2024

Claims for Patent: 7,879,976

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Summary for Patent: 7,879,976

Title:	Method for stabilizing a protein
Abstract:	The invention relates to a method for stabilizing an aqueous protein solution against exogenous stress and to the use of a container for stabilizing an aqueous protein solution.
Inventor(s):	Friess; Wolfgang (Iffeldorf, DE), Kiese; Sylvia (Zurich, CH), Mahler; Hanns-Christian (Basel, CH), Pappenberger; Astrid (Bettingen, CH)
Assignee:	Hoffmann-La Roche Inc. (Nutley, NJ)
Application Number:	12/109,435
Patent Claims:	1. A method for stabilizing an aqueous protein solution against exogenous stress comprising the step of filling a container with said aqueous protein solution so that the container substantially lacks a gas headspace when closed. 2. The method according to claim 1, wherein the lack of gas headspace is pre-determined either visually, gravimetrically or volumetrically. 3. The method according to claim 1 wherein the container is filled at about more than 97% of the total volume of the container. 4. The method according to claim 1 wherein the gas headspace represents less than about 3% of the total volume of the container. 5. The method according to claim 1 wherein the gas headspace represents less than about 2% of the total volume of the container. 6. The method according to claim 1 wherein the gas headspace represents less than about 1% of the total volume of the container. 7. The method according to claim 1, wherein the protein is an antibody. 8. The method according to claim 1, wherein the protein is a monoclonal antibody. 9. The method according to claim 8, wherein the monoclonal antibody is selected from the group consisting of: IgG1, IgG2, and IgG4. 10. The method according to claim 9, wherein the monoclonal antibody is against at least one of the following targets: IGF-1R, CD20, CD19 CCR5, amyloid, OX40, EGF receptor, VEGF, HER, IL1R, IL13, IL6, IL17 and P-selecting. 11. The method according to claim 10, wherein the monoclonal antibody is selected from the group consisting of: Actemra, Avastin, and Herceptin. 12. The method according to claim 1 wherein the aqueous protein solution lacks a stabilizer against exogenous stress. 13. The method according to claim 12 wherein the exogenous stress is a mechanical stress. 14. The method according to claim 13 wherein the mechanical stress is shaking. 15. The method according to claim 1 wherein the exogenous stress occurs at a temperature of between 0 to 40.degree. C. 16. The method according to claim 1 wherein the aqueous protein solution comprises water and a protein. 17. The method according to claim 1 wherein the aqueous protein solution comprises pharmaceutically acceptable excipients. 18. The method according to claim 1 wherein the aqueous protein solution substantially lacks significant turbidity and/or aggregation and/or visible particles upon shaking. 19. The method according to claim 1 wherein the container is not an injection device. 20. The method according to claim 1 wherein the container is not a syringe. 21. The method according to claim 1 wherein the container comprises a recipient part connected to an opening and a closing means. 22. The method according to claim 1 wherein the container consists of a recipient connected to an opening and a closing means.

Details for Patent 7,879,976

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998	⤷ Try a Trial	2027-05-02
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017	⤷ Try a Trial	2027-05-02
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004	⤷ Try a Trial	2027-05-02
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125276	01/08/2010	⤷ Try a Trial	2027-05-02
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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