ABSTRACT
Humatrope is produced by recombinant DNA technology in E. coli cells. It is initially synthesized with an additional methionine residue at the N-terminus, but this is cleaved as the polypeptide is transported naturally into the cell’s periplasmic space. Biologically active somatropin, identical to the native human molecule, is extracted from the periplasmic space subsequent to fermentation. The molecule is then purified using a number of chromatographic steps. The final product is presented in lyophilized form in vials and cartridges, with a solvent to be used in reconstitution prior to subcutaneous or intramuscular administration. The cartridges are used with a multidose device called HumatroPen.
