High protein concentration formulations containing mannitol

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/19 (2006.01) A61K 39/395 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2671571

The present invention provides a method for inhibiting mannitol-induced aggregation of a protein in a liquid formulation by increasing the protein concentration to an amount greater than 50 mg/ml. The present invention also provides methods for storing and preparing a liquid formulation containing mannitol and a protein concentration greater than 50 mg/ml.

La présente invention concerne un procédé pour inhiber l'agrégation induite par le mannitol d'une protéine dans une formulation liquide en augmentant la concentration de protéines jusqu'à une valeur supérieure à 50 mg/ml. La présente invention concerne également des procédés pour stocker et préparer une formulation liquide contenant du mannitol et une concentration de protéines supérieure à 50 mg/ml.

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