Interleukin-13 Antibody Composition

Abstract

The invention relates to a pharmaceutical composition comprising an interleukin-13 antibody, more particularly a monoclonal interleukin-13 antibody, especially a human interleukin-13 monoclonal antibody, to a process for purifying said antibody and to the use of said composition in treating interleukin-13 related disorders, such as asthma, atopic dermatitis, allergic rhinitis, fibrosis, chronic obstructive pulmonary disease, scleroderma, inflammatory bowel disease and Hodgkin's lymphoma, particularly asthma.

1 . A pharmaceutical composition comprising an IL-13 antibody and one or more pharmaceutically acceptable excipients buffered to a pH of 4.5-6.0 with acetate buffer. 
     
     
         2 . A pharmaceutical composition as defined in  claim 1  wherein the IL-13 antibody is a human IL-13 monoclonal antibody. 
     
     
         3 . A pharmaceutical composition as defined in  claim 1  wherein the IL-13 antibody is present within the pharmaceutical composition in an amount of between 1 and 200 mg/ml 
     
     
         4 . A pharmaceutical composition as defined in  claim 1  which is buffered to a pH of 5.2 to 5.7 
     
     
         5 . A pharmaceutical composition as defined in  claim 1  which comprises sodium acetate present within the pharmaceutical composition in an amount of between 1 and 100 mM. 
     
     
         6 . A pharmaceutical composition as defined in  claim 1  wherein the pharmaceutically acceptable excipient comprises one or more surfactant, inorganic or organic salt, stabilizer, diluent, solubilizer, reducing agent, antioxidant, chelating agent and/or preservative. 
     
     
         7 . A pharmaceutical composition as defined in  claim 6  wherein the surfactant is selected from a polyoxyethylene sorbitan fatty acid ester. 
     
     
         8 . A pharmaceutical composition as defined in  claim 7  wherein the surfactant is Polysorbate 80 present within the pharmaceutical composition in an amount of between 0.001 and 0.1% (w/w). 
     
     
         9 . A pharmaceutical composition as defined in  claim 6  wherein the inorganic salt comprises sodium chloride, potassium chloride, calcium chloride, sodium phosphate, potassium phosphate and sodium bicarbonate. 
     
     
         10 . A pharmaceutical composition as defined in  claim 9  wherein the inorganic salt is sodium chloride present within the pharmaceutical composition in an amount of between 10 and 200 mM. 
     
     
         11 . A pharmaceutical composition as defined in  claim 1  which comprises an IL-13 antibody, a surfactant and an inorganic salt buffered to a pH of 5.5±0.1 with acetate buffer. 
     
     
         12 . A pharmaceutical composition as defined in  claim 1  which comprises an IL-13 antibody, sodium chloride and Polysorbate 80 buffered to a pH of 5.5±0.1 with sodium acetate buffer. 
     
     
         13 . A pharmaceutical composition as defined in  claim 1  which comprises 50 mg/ml of an IL-13 antibody, 85 mM sodium chloride and 0.01% (w/w) Polysorbate 80 buffered to a pH of 5.5±0.1 with 50 mM sodium acetate buffer. 
     
     
         14 . A process for purifying an IL-13 antibody which comprises one or more chromatographic separation steps wherein each of said separation steps comprises elution with an elution buffer comprising one or more pharmaceutically acceptable excipients buffered to a pH of 3.5-7.0 with acetate buffer. 
     
     
         15 . A process as defined in  claim 14  wherein the chromatographic separation steps are selected from affinity chromatography and ion exchange chromatography. 
     
     
         16 . A process as defined in  claim 15  wherein the chromatographic separation is performed by Protein A affinity chromatography followed by cation exchange chromatography followed by anion exchange chromatography. 
     
     
         17 . A process as defined in  claim 14  wherein the one or more pharmaceutically acceptable excipients comprises an inorganic salt. 
     
     
         18 . A process as defined in  claim 17  wherein the inorganic salt is sodium chloride present within the elution buffer in an amount of between 10 and 200 mM. 
     
     
         19 . A process as defined in  claim 14  wherein acetate buffer is sodium acetate present within the elution buffer in an amount of between 1 and 100 mM 
     
     
         20 . A process as defined in  claim 14  wherein the elution buffer comprises 50 mM sodium acetate and 85 mM sodium chloride buffered to pH 5.5±0.1. 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . (canceled) 
     
     
         24 . A method of treatment or prophylaxis of an IL-13 related disorder which comprises administering to the sufferer a therapeutically effective amount of a pharmaceutical antibody composition as defined in  claim 1 . 
     
     
         25 . (canceled) 
     
     
         26 . The method of treatment of  claim 24 , wherein the IL-13 related disorder is selected from asthma, atopic dermatitis, allergic rhinitis, fibrosis, chronic obstructive pulmonary disease, scleroderma, inflammatory bowel disease and Hodgkin's lymphoma. 
     
     
         27 . The method of treatment of  claim 24 , wherein the IL-13 related disorder is asthma.