Elaprase Description

Each vial contains extractable volume of 3 mL with an idursulfase concentration of 2 mg/mL at a pH of approximately 6, providing idursulfase 6 mg, sodium chloride 24 mg, monobasic sodium phosphate monohydrate 6.75 mg, dibasic sodium phosphate heptahydrate 2.97 mg and polysorbate 20 0.66 mg.
Elaprase does not contain preservatives and is for single use only.
Elaprase is a formulation of idursulfase, a purified form of human iduronate-2-sulfatase, a lysosomal enzyme. Idursulfase is produced by recombinant DNA technology in a human cell line. Idursulfase is an enzyme that hydrolyzes the 2-sulfate esters of terminal iduronate sulfate residues from the glycosaminoglycans (GAG) dermatan sulfate and heparan sulfate in the lysosomes of various cell types.
Idursulfase is a 525-amino acid glycoprotein with a molecular weight of approximately 76 kilodaltons. The enzyme contains 8 asparagine-linked glycosylation sites occupied by complex oligosaccharide structures. The enzyme activity of idursulfase is dependent on the post-translational modification of a specific cysteine to formylglycine. Idursulfase has a specific activity ranging from protein 46-74 u/mg (1 unit is defined as the amount of enzyme required to hydrolyze 1 micromole of heparin disaccharide substrate per hour under the specified assay conditions).