Stable protein formulations
AssigneeBristol-Myers Squibb Company
InventorsManisha M. Dali, Charles E. Dahlheim, Sunita Borsadia, Vijay H. Naringrekar, Rajesh Babulal Gandhi, Manoj Nerurkar
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Abstract
The present invention relates generally to stable formulations comprising CTLA4Ig molecules, including lyophilized, and liquid formulations for administration via various routes including, for example, routes such as intravenous (IV) and subcutaneous (SC) for treating immune system diseases and tolerance induction.
Claims15
A stable formulation suitable for subcutaneous administration comprising at least 100mg/ml CTLA4Ig molecule, a sugar selected from the group consisting of sucrose, lactose, maltose, mannitol and trehalose and mixtures thereof and a pharmaceutically acceptable aqueous carrier, wherein the formulation has a pH range of from 6 to 8 and a viscosity of from 9 to 20 cps, and the weight ratio of sugar:protein is 1.1:1 or higher.
A stable formulation comprising the CTLA4Ig molecule having the amino acid sequence shown in SEQ ID NO:2 starting at methionine at position 27 or alanine at position 26 and ending at lysine at position 383 or glycine at position 382 in an amount of about 125 mg/ml, sucrose in an amount of about 170 mg/ml, at least one buffering agent, sterile water for injection and optionally a surfactant.
Dependencies are inferred from the claim text.