Recombinant alternatives to proteins purified from plasma or human and animal materials were the backbone of the early biotech industry—at least 16 have become blockbusters. For example, recombinant insulin for diabetes now accounts for more than 70% of the worldwide human insulin market. Other successful recombinant products include erythropoietin, interferon alpha and human growth hormone.
One of the main innovators in the recombinant protein sphere has been Genzyme of Cambridge, Massachusetts. Tim Edmunds, Genzyme's vice president of therapeutic protein research, believes there are no longer any convincing reasons to use 'natural' products now that technology can produce large quantities of recombinant proteins by cell culture or transgenic means. He cites several examples of a switch from natural to recombinant product where improved safety has been at least a factor. Genzyme's own Cerezyme (imiglucerase), for example, is a recombinant form of the enzyme glucocerebrosidase to treat Gaucher's disease and was launched as a follow-on to placental-derived enzyme Ceredase (alglucerase). It succeeded partly because there were not enough placentas to meet demand for Ceredase, but also, says Edmunds, “because regulatory agencies were becoming increasingly concerned about human-derived products, even though that has never been an issue with Ceredase itself.”
This is a preview of subscription content, access via your institution