Stabilized liquid polypeptide formulations

A - Human Necessities – 61 – K

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A61K 39/395 (2006.01) C07K 16/18 (2006.01)

Patent

CA 2595380

The present invention provides formulations for maintaining the stability of polypeptides, in particular, therapeutic antigen-binding polypeptides such as antibodies and the like, for example, anti-A.beta. antibodies. The formulations generally include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine, and thus, the formulations are suitable for several different routes of administration.

La présente invention concerne des formulations pour préserver la stabilité de polypeptides, en particulier de polypeptides thérapeutiques de liaison à l'antigène tels que des anticorps et analogue, par exemple des anticorps anti-Aß. Les formulations comprennent de manière générale un antioxydant en une quantité suffisante pour inhiber la formation de produits secondaires, par exemple la formation d'agrégats polypeptidiques à haut poids moléculaire, de fragments de dégradation polypeptidiques à bas poids moléculaire, et de mélanges de ceux-ci. Les formulations de l'invention comprennent éventuellement un agent de tonicité tel qu'un mannitol, et un agent tampon ou un acide aminé tel que l'histidine, et sont ainsi compatibles avec différentes voies d'administration.

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