METODO DE PURIFICACION DE INTERFERON-BETA

• Main Authors: BABUKA, SUSAN, WOLFE, SID, SHIRLEY, BRET, A, ESIKOVA, IRINA, FORDHAM, DENNIS
• Format: Patent
• Language: Spanish
• Published: 01.06.2008
• Subjects: CHEMISTRY; HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; METALLURGY; ORGANIC CHEMISTRY; PEPTIDES; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

Un método para preparar una composición que comprende interferón-beta (IFN-beta) monómero, cuyo método comprende: a) preparar una muestra que comprende IFN-beta purificado; b) mezclar dicha muestra con hidrocloruro (HCl) de guanidina para obtener una primera solución que comprende IFN-beta desnaturalizado solubilizado; y c) renaturalizar dicho IFN-beta por dilución de dicha primera solución con un primer tampón, en el que dicho primer tampón tiene un pH de 3,0 a 5,0, y en el que se obtiene una solución de IFN-beta renaturalizado que comprende IFN-beta monómero e HCl de gunidina residual. Improved methods for purification and recovery of interferon-beta (IFN- ) and compositions comprising substantially monomeric IFN- are provided. In one purification method, substantially purified IFN- 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- , residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN- .