Patent ID: 8178108
Filing Date: 2012-05-15
Classification: A61P,C07K

Abstract:
1. A process of producing water soluble polymer-human growth hormone (hGH) polypeptide conjugate with a serum half-life at least two-fold greater than the serum half-life of a naturally occurring, unconjugated version of an hGH protein, comprising: a) culturing recombinant host cells capable of expressing an hGH polypeptide comprising a non-naturally encoded amino acid having the structure: wherein the R group is any substituent other than one used in the twenty natural amino acids in a liquid nutrient medium containing the non-naturally encoded amino acid under conditions which favor growth; b) expressing the hGH polypeptide at a concentration of at least 500 mg/L; c) eluting; d) collecting; e) substantially purifying said hGH polypeptide from said cells or culture medium by conjugating said non-naturally encoded amino acid in said hGH polypeptide to a water soluble polymer, wherein said non-naturally encoded amino acid is substituted at a position selected from the group consisting of amino acid positions 35, 92, 131, 134, 143, and 145 or any combination thereof from SEQ ID NO: 2 or the corresponding amino acids of SEQ ID NO: 1 or 3, f) contacting the conjugated hGH with an anion exchange chromatography matrix under conditions that allow binding of the hGH polypeptide to the matrix g) eluting the matrix from e) and collecting the water soluble polymer-human growth hormone (hGH) polypeptide conjugate.