ABSTRACT
Dornase alfa is a recombinant human DNase I, an endonuclease similar to the natural molecule. The human gene has been cloned and expressed in a CHO cell line and is purified from the culture medium using multiple chromatographic and filtration procedures. The antibiotic gentamicin is used during fermentation, but no traces are detectable in the final, purified product. The final product is presented after extensive characterization as a solution to be administered for inhalation using an aerosol nebulizer device. Pulmozyme contains the active substance dornase alfa, as well as dihydrate calcium chloride and sodium chloride as excipients.
