STABLE ANTIBODY COMPOSITIONS AND METHODS OF STABILIZING SAME
The invention provides compositions and methods for inhibiting fractionation of immunoglobulins comprising a lambda light chain based on the observation that iron, in the presence of histidine, results in increased fragmentation of a recombinant fully human IgG molecule containing a lambda light chain due to cleavage in the hinge region. The invention further provides an aqueous pharmaceutical formulation comprising an antibody, or antigen-binding portion thereof, that binds the p40 subunit of IL-12/IL-23 and a buffer system comprising histidine, wherein the formulation has enhanced stability, including enhanced resistance to fragmentation.
1 .- 144 . (canceled)
145 . A pharmaceutical formulation comprising:
(a) 45 mg of antibody C340,
(b) 1-10% sucrose,
(c) 0.001-0.1% polysorbate 80, and
(d) a buffer system comprising 1-50 mM histidine and having a pH of 5.7 to 6.3.
146 . A pharmaceutical formulation comprising:
(a) 90 mg/mL of antibody C340,
(b) 1-10% sucrose,
(c) 0.001-0.1% polysorbate 80, and
(d) a buffer system comprising 1-50 mM histidine and having a pH of 5.7 to 6.3.
147 . The formulation of claim 145 , wherein the formulation has a pH of about 6.
148 . The formulation of claim 145 , wherein the histidine comprises L-histidine.
149 . The formulation of claim 145 , wherein the formulation has a shelf life of at least 18 months.
150 . The formulation of claim 146 , wherein the formulation has a pH of about 6.
151 . The formulation of claim 146 , wherein the histidine comprises L-histidine.
152 . The formulation of claim 146 , wherein the formulation has a shelf life of at least 18 months.
153 . A method of treating a subject having a disorder in which the activity of the p40 subunit of IL-12 and/or IL-23 is detrimental, the method comprising administering the formulation of claim 145 to the subject, thereby treating the subject.
154 . The method of claim 153 , wherein the disorder is psoriasis.
155 . The method of claim 153 , wherein the disorder is psoriatic arthritis.
156 . The method of claim 153 , wherein the formulation is subcutaneously administered to the subject.
157 . A method of treating a subject having a disorder in which the activity of the p40 subunit of IL-12 and/or IL-23 is detrimental, the method comprising administering the formulation of claim 146 to the subject, thereby treating the subject.
158 . The method of claim 157 , wherein the disorder is psoriasis.
159 . The method of claim 157 , wherein the disorder is psoriatic arthritis.
160 . The method of claim 157 , wherein the formulation is subcutaneously administered to the subject.