Stable high protein concentration formulations of human...

A - Human Necessities – 61 – K

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A61K 39/395 (2006.01) A61K 9/08 (2006.01) C07K 16/24 (2006.01)

Patent

CA 2760185

The invention provides a liquid pharmaceutical formulation which does not include NaCl and comprises more than 20 mg of a polyol and at least about 100 mg/mL of a human anti-TNF- alpha antibody, or antigen-binding portion thereof. The invention provides a high concentration antibody formulation having long-term stability and advantageous characteristics for subcutaneous administration.

L'invention concerne une formulation pharmaceutique liquide qui ne contient pas de NaCl et qui renferme plus de 20 mg d'un polyol et au moins environ 100 mg/ml d'anticorps anti-TNF-alpha humain ou de sa partie se liant à l'antigène. L'invention concerne une formulation d'anticorps à concentration élevée présentant une stabilité à long terme et des caractéristiques avantageuses pour une administration sous-cutanée.

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