Process for gram scale production of PEG-r-metHuG-CSF
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United States of America Patent
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Nov 19, 2013
Grant Date -
Aug 11, 2011
app pub date -
May 4, 2009
filing date -
Oct 20, 2008
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Abstract
The present invention relates to a process for improving pegylation reaction yield of r-metHuG-CSF comprising conjugating r-metHuG-CSF to a PEG aldehyde at a free amine moiety at the N terminal end on the G-CSF in presence of a reducing agent in a pegylation buffer solution comprising a polyol having the formula CnH2n+2On where n is from 3 to 6, or a carbohydrate, or a derivative thereof wherein the concentration of said polyol or carbohydrate or derivative thereof is in the range of 0.1% to 10% w/w.
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