Loading patent…
AssigneeMedImmune, LLC
InventorsPer-Olof Fredrik Eriksson, Karin Von Wachenfeldt, Suzanne Cohen, Claire Louise Dobson, Deborah Louise Lane, Katrina Day
Estimating the term…
The present invention relates to a stable, low viscosity antibody formulation, wherein the formulation comprises a high concentration of anti-IL4R antibody. In some embodiments, the invention relates in general to a stable antibody formulation comprising about 100 mg/mL to about 200 mg/mL of an antibody or fragment thereof that specifically binds human interleukin-4 receptor alpha (hIL-4Rα), about 50 mM to about 400 mM of a viscosity modifier; about 0.002% to about 0.2% of a non-ionic surfactant; and a formulation buffer. In some embodiments, the formulation buffer is essentially free of phosphate. In some embodiments, the invention is directed to a container, dosage form and/or kit. In some embodiments, the invention is directed to a method of making and using the stable antibody formulation.
-30. (canceled)
A stable antibody formulation comprising:
The antibody formulation of claim 1, wherein the antibody or fragment thereof comprises an antibody VH domain and an antibody VL domain, wherein the VH domain comprises HCDR1, HCDR2, HCDR3 and a first framework and the VL domain comprises LCDR1, LCDR2, LCDR3 and a second framework.
The antibody formulation of claim 1, wherein the formulation buffer is essentially free of phosphate.
The antibody formulation of claim 1, wherein the non-ionic surfactant is selected from the group consisting of Triton X-100, Tween 80, polysorbate 20, polysorbate 80, nonoxynol-9, polyoxamer, stearyl alcohol, or sorbitan monostearate.
The antibody formulation of claim 1, wherein the formulation buffer is an acetate buffer, TRIS buffer, HEPES buffer, hydrochloride buffer, arginine buffer, histidine buffer, glycine buffer, citrate buffer, or TES buffer.
The antibody formulation of claim 1, wherein the formulation further comprises about 100 mM to about 200 mM NaCl.
The antibody formulation of claim 1, wherein the formulation has a pH of about 5 to about 8.
The antibody formulation of claim 1, wherein the antibody or fragment thereof comprises a VH and a VL domain wherein:
The antibody formulation of claim 1, wherein said formulation is stable upon storage at about 40° C. for at least 1 month;
The antibody formulation of claim 1, wherein the antibody stored at about 40° C. for at least 1 month retains at least 80% or at least 50% of binding ability to an hIL-4Rα polypeptide compared to a reference antibody that has not been stored.
The antibody formulation of claim 1, wherein the antibody stored at about 5° C. for at least 6 month retains at least 80% or at least 50% of binding ability to an hIL-4Rα polypeptide compared to a reference antibody that has not been stored.
The antibody formulation of claim 1, wherein the formulation has a viscosity of less than 20 cP at 23° C.
A stable antibody formulation comprising:
A pharmaceutical unit dosage form suitable for parenteral administration to a human which comprises the antibody formulation of claim 1 in a suitable container.
A method for treating a pulmonary disease or disorder or a chronic inflammatory skin disease or disorder in a subject, the method comprising administering a therapeutically effective amount of the antibody formulation of claim 1.
Dependencies are inferred from the claim text.