Methods of purification and recovery of interferon-beta

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....

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Bibliographic Details
Main Authors IRINA ESIKOVA, BRET A. SHIRLEY, SUSAN BABUKA, DENNIS FORDHAM, SID WOLFE
Format Patent
LanguageEnglish
Published 19.10.2006
Subjects
CHEMISTRY
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
METALLURGY
ORGANIC CHEMISTRY
PEPTIDES
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Summary: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- .
Bibliography:Application Number: AU20020234161