Method of filling a container with no headspace
AssigneeCoherus Biosciences, Inc.
InventorsJohn Ogez, Jun Liu, Wenchang Ji, Patrick Daniel Begley, Isaias Prado, Mark Manning
Life of this patent
Estimating the term…
Abstract
The present invention is directed to methods for filling a container wherein the filled container has no headspace. The present invention is further directed to methods for stabilizing an aqueous drug substance solution by filling a container with the aqueous drug substance solution wherein the filled container has no headspace. The present invention is further directed to methods for detecting headspace in a container.
Claims62
A method for preparing a container with zero headspace comprising an aqueous drug substance solution, the method comprising:
- a) providing a container with an open end;
- b) providing an aqueous drug substance solution;
- c) filling the container via the open end with the aqueous drug substance solution;
- d) purging the container with at least one soluble gas;
- e) inserting a stopper into the open end of the container creating a headspace of soluble gas;
- and
- f) storing the container,
- wherein the stopper can move within the container while maintaining an airtight seal;
- and the storing step results in the container having zero headspace.
A container closed with a stopper, wherein the container comprises a stable aqueous drug substance solution within the container and zero headspace, wherein the volume of the aqueous drug substance solution is less than 100% of the container volume.
A stable pharmaceutical composition comprising:
- a) adalimumab,
- b) stabilizer comprising an amino acid, and
- c) salt;
- wherein the composition is free of buffer, polyol, and surfactant;
- has a pH of about 5 to about 6;
- and has a conductivity of greater than 3.0 mS/cm.
A stable pharmaceutical composition in a container with zero headspace, the composition comprising:
- a) adalimumab,
- b) stabilizer comprising an amino acid, and
- c) salt;
- wherein the composition is free of buffer, polyol, and surfactant;
- has a pH of about 5 to about 6;
- and has a conductivity of greater than 3.0 mS/cm.
Dependencies are inferred from the claim text.