Method for stabilizing a protein
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.
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° 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.