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AssigneeRegeneron Pharmaceuticals, Inc.
InventorsHanne BAK, John MATTILA, Ning LI, Xiaolin TANG, Daniel DIX, Chen LI, William MARKIS
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The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.
A composition comprising (a) a protein, (b) an intact fatty acid ester, and (c) (i) no more than 400 subvisible particles of 10 microns or greater in diameter, or (ii) no more than 10,000 subvisible particles of 2 microns or greater in diameter.
A process for manufacturing a stable protein formulation comprising the step of filling a container with a formulated drug substance, which is essentially free of esterase activity and which contains a protein and a fatty acid ester, wherein the formulated drug substance is essentially free of subvisible particles.
Dependencies are inferred from the claim text.