Methods of interferon-β purification and recovery

US8388942B2 · kind B2 · utility

Assignee

• Novartis Vaccines and Diagnostics, Inc. · US

Inventors

• Sidney N. Wolfe · Richmond, US
• Bret A. Shirley · Concord, US
• Susan Babuka · Oakland, US
• Dennis Fordham · Richmond, US
• Irina Esikova · Fremont, US

Key dates

• Filing date: Apr 29, 2008
• Grant date: Mar 5, 2013
• Expiry date: Jan 17, 2030

Classification

• Technology area (CPC C): Chemistry; Metallurgy
• CPC primary: C07K14/565
• WIPO field: Biotechnology
• WIPO sector: Chemistry

Abstract

Improved methods for purification and recovery of interferon-beta (IFN-β) and compositions comprising substantially monomeric IFN-β are provided. In one purification method, substantially purified IFN-β or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HCl) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-β, residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-β.