Jeg faldt over dette. Uden at jeg lige helt forstår det, så har GSK vist fået patent på en metode til at stabilisere ofatumumab og andre antibodies (?)
http://www.freepatentsonline.com/y2011/0020328.html
SUMMARY OF THE INVENTION
The present invention relates to a shear and temperature stable aqueous antibody formulation.
In another embodiment, the invention relates to an anti-CD20 antibody formulation comprising an anti-CD20 antibody in the concentration range of 20-300 mg/mL, wherein the formulation further comprises 50 mM sodium acetate, 51 mM sodium chloride, 1% arginine free base, 0.05 mM EDTA, 0.02% polysorbate 80, and adjusted to pH 5.5. In another embodiment, the antibody is an anti-CD20 antibody fragment, such as a monoclonal antibody fragment. The preferred anti-CD20 antibody is ofatumumab.
In one embodiment, the invention relates to an ofatumumab formulation comprising a therapeutically effective amount of ofatumumab, wherein the formulation further comprises 10 to 100 mM sodium acetate, 25 to 100 mM sodium chloride, 0.5 to 5% arginine free base, 0.02 to 0.2 mM EDTA, 0.01 to 0.2% polysorbate 80 and adjusted to pH 5.0 to 7.0.
In one embodiment, the invention relates to an ofatumumab formulation comprising an ofatumumab in the concentration range of 20-300 mg/mL, wherein the formulation further comprises 50 mM sodium acetate, 51 mM sodium chloride, 1% arginine free base, 0.05 mM EDTA, 0.02% polysorbate 80, and adjusted to pH 5.5.
