N-terminal polysialylation
AssigneeLipoxen Technologies Limited
InventorsSanjay Jain, Rongsheng Zhang
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Abstract
The present invention relates to a composition comprising a population of polysaccharide derivatives of a protein, wherein the protein is insulin or an insulin-like protein and the polysaccharide is anionic and comprises between 2 and 125 saccharide units, and wherein the population consists of substantially only N-terminal derivatives of the protein. Typically, the polysaccharide is PSA. The present invention also relates to pharmaceutical compositions comprising the novel compounds, and methods for making the novel compounds.
Claims23
A method for producing a population of amino-terminal polysialic acid derivatives of insulin the method comprising:
- performing a derivatization reaction in a first aqueous solution at pH 6.0 which couples a polysialic acid comprising 2-125 sialic acid units to only the amino-terminal amine of the B-chain of the insulin, thereby producing the population of amino-terminal polysialic acid derivatives of insulin;
- and
- purifying the population of amino-terminal polysialic acid derivatives of insulin using a chromatographical method and eluting in a second aqueous solution at pH 7.4,
- wherein at least 85% of the population of amino-terminal polysialic acid derivatives of insulin consists of a polysialic acid coupled only at the amino-terminal amine of the B-chain of the insulin.
Dependencies are inferred from the claim text.