ABSTRACT

Rebif is a recombinant human IFN-β-1a. The gene has been cloned into a modified CHO cell line, and the product, similar to the natural interferon, is purified from the culture medium. Purification involves a number of chomatographic steps (affinity, ion-exchange, size exclusion, and reversedphase liquid chromatography) and filtration procedures. The final product consists of IFN-β-1a (active), as well as mannitol, human serum albumin, sodium acetate, acetic acid, and sodium hydroxide as excipients. Rebif is provided as a solution in a prefilled syringe for subcutaneous administration.