A process for modification of recombinant human interferon for therapeutic use

PK140586AUndetermined Publication Date: 2010-03-30NAT CENT OF EXCELLENCE IN MOLECULAR BIOLOGY
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Patent Information

Application Number
PK200900683
Authority / Receiving Office
PK · PK
Patent Type
Applications
Current Assignee / Owner
Publication Date
2010-03-30
Patent Text Reader

Abstract

The present invention relates to a process for modification of recombinant human interferon for therapeutic use comprising offollowing four main steps: Step 1: Concentration of the interferon and contemporary change of pH of the protein solution. Step 2: Pegylation reagent reacts with interferon under strictly controlled conditions of molar ratio, pH, temperature and time. Step 3: Separation of the monopegylated interferon of interest from the oligomers and from the non-reacted interferon. Step 4: This step involves quality control of the purified PEG-IFN: in vitro RPHPLC, Size exclusion chromatography, SDS-PAGE, UV quantification.
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