Stable formulations of polypeptides and uses thereof

US9265834B2 · kind B2 · utility

Assignee

• Ablynx N.V. · BE

Inventors

• Ann Brigé · Ertvelde, BE
• Christine Labeur · Brugge, BE
• Veronique De Brabandere · Evergem, BE
• Marc Jozef Lauwereys · Haaltert, BE

Key dates

• Filing date: Aug 12, 2013
• Grant date: Feb 23, 2016
• Expiry date: Aug 12, 2033

Classification

• Technology area (CPC C): Chemistry; Metallurgy
• CPC primary: C07K2317/94
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

Formulations are provided that contain single variable domains with a good solubility and good stability under different storage, transportation and stress conditions. The formulations are useful as pharmaceutical formulation. The formulation comprises an aqueous carrier with a pH of 5.5 to 8.0, a buffer selected from the group consisting of histidine pH 6.0-6.5, hepes pH 7.0-8.0, MES pH 6.0, succinate pH 6.0-6.5 and acetate pH 5.5-6.0; an excipient; and/or a surfactant selected from polysorbate 80, polysorbate 20 and poloxamers. The formulation is further characterized that it has an inorganic salt concentration of 150 mM or lower.