Novel Formulations Which Stabilize Low Dose Antibody Compositions
AssigneeJanssen Biotech, Inc.
InventorJoanna Mackay
Life of this patent
Estimating the term…
Abstract
The present invention addresses an ongoing need in the art to improve the stability of antibody compositions. The invention broadly relates to novel formulations which stabilize and inhibit protein adsorption of low dose antibody compositions in a container means comprising a coating. More particularly, the invention described hereinafter, addresses a need in the art for formulations which stabilize and inhibit protein adsorption of low dose antibody compositions which are processed, developed, formulated, manufactured and/or stored in container means such as tormentors, bioreactors, vials, flasks, bags, syringes, rubber stoppers, tubing and the like.
Claims15
A formulation which stabilizes an antibody composition, the formulation comprising (i) a pH buffered solution with a pH of about 5 to about 7.4, (ii) a polysorbate and (iii) one or more antibodies at a dose of less than about 70 μg, wherein the formulation is contained in a container means with a coating.
A formulation which stabilizes an anti-CD3 bispecific antibody composition, the formulation comprising (i) a pH buffered solution with a pH of about 5 to about 7.4 and (ii) a polysorbate, and (iii) an anti-CD3 bispecific antibody at a dose of less than about 70 μg wherein the formulation is contained in a container means with a coating.
A method for containing an antibody composition comprising providing an antibody composition ready for injection and comprising at least one antibody as an active ingredient at a dose of less than about 70 μg into a container means with a coating wherein the pharmaceutical composition is in a formulation comprising (i) a pH buffered solution with a pH of about 5 to about 7.4 and (ii) a polysorbate.
Dependencies are inferred from the claim text.