Novartis Vaccines & Diagnostics, Gmbh

Chiron Corporation

Susan Babuka

Bret A Shirley

Maninder S Hora

Bao-lu Chen

Minna Choe

Melanie Tellers

Sidney N Wolfe

Dennis Fordham

Irina Esikova

Bao-Lu Chen

Bret Shirley

Improved methods for purification and recovery of interferon-beta (IFN-&#x3b2;) and compositions comprising substantially monomeric IFN-&#x3b2; are provided. In one purification method, substantially purified IFN-&#x3b2; 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-&#x3b2;, residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-&#x3b2;.

Methods of interferon-&#x3b2; purification and recovery

Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-&#x3b2;) and methods useful in their preparation are provided. The compositions comprise the IFN-&#x3b2; solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN-&#x3b2; in pharmaceutical compositions, are provided.

HSA-free formulations of interferon-Beta

HSA-free formulations of interferon-&#x3b2;

Methods of protein purification and recovery

HSA-free formulations of interferon-beta

Growing community of inventors

Oakland, CA, United States of America

Susan Babuka