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AssigneeRegeneron Pharmaceuticals, Inc.
InventorsPaul Conroy, John Crowley, Marguerita McCarthy, Kathleen O'Dwyer, Shunhai Wang, Sisi Zhang, Yuetian Yan, Tyler Greer, Siobhan Hogan, Xiaojing Zheng, Hui Xiao, Ning Li, Lili Guo, Yuan Mao, Prerana Mantri, Evan Koufos, Kathir Muthusamy, Nisha Palackal, Erica Pyles
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Anti-VEGF proteins including the VEGF trap protein aflibercept can be produced to have a low level of an aspartyl protease (e.g., a low level of cathepsin D), such as less than 1 ppm of the aspartyl protease.
A formulation comprising one or more pharmaceutically acceptable excipients, aflibercept at a concentration of from about 100 mg/mL to about 200 mg/mL and a residual amount of cathepsin D of less than about 1 ppm, wherein the formulation exhibits a reduced level of NR1 species relative to a formulation having greater than 1 ppm cathepsin D.
A formulation suitable for administration to a human subject comprising one or more pharmaceutically acceptable excipients, between about 100 mg/mL and 200 mg/mL of aflibercept, and having less than 1 ppm of cathepsin D;
A concentrated pool comprising aflibercept at a concentration from about 120 mg/mL to about 200 mg/mL, and an amount of less than about 1 ppm of cathepsin D, wherein the concentrated pool exhibits a reduced level of NR1 species relative to a concentrated pool having greater than 1 ppm cathepsin D.
A composition, comprising aflibercept, a pharmaceutically acceptable excipient, and a residual amount of cathepsin D;
Dependencies are inferred from the claim text.