Stable IgG4 based binding agent formulations

US9592289B2 · kind B2 · utility

Assignee

• Sanofi · FR

Inventors

• Julia Schnieders · Frankfurt, DE
• Dirk Usener · Wiesbaden, DE
• Sabrina Ruggeberg · Frankfurt, DE
• Ahmed Abouelfetouh Youssef · Greenwood, US
• Martina Kirsch · Frankfurt, DE
• Annika Hagendorf · Hattersheim, DE

Key dates

• Filing date: Mar 26, 2013
• Grant date: Mar 14, 2017
• Expiry date: Mar 26, 2033

Classification

• Technology area (CPC C): Chemistry; Metallurgy
• CPC primary: C07K2317/565
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

The present invention provides stable pharmaceutical antibody formulations, including liquid drug product formulations and lyophilized drug product formulations, comprising an IgG4 binding agent and a citrate buffer, wherein the pH of the formulation is at or below both pH 6 and the pI of the binding agent. The formulations can be used in the treatment of chronic bowel diseases or rheumatoid arthritis.