Genzyme's New Production Plant

Return to contents page

Seventy members of the US National Gaucher Foundation visited Genzyme's new production plant in Allston, Massachusetts, on 10 March 1996, where the recombinant enzyme replacement therapy, Cerezyme, is due to be made. Currently a minority of patients are receiving Cerezyme in the United States, Israel, France, Sweden and Canada. Wayne Rosenfield reports via the Internet:

We toured the plant, seeing the bio-reactors, purification tanks and freeze-drying chambers from the observation windows.

Several of us agreed on the tour to pose some direct questions to the Genzyme employee giving us the narrative and at least one answer was quite surprising: currently no Gaucher patients are receiving Cerezyme from this incredibly large production plant. All of the Cerezyme being distributed is produced at a much smaller plant in Framingham, Massachusetts.

Gearing Up

The Allston facility is still gearing up and the production has not yet been certified by the FDA. (In the US, the Food and Drug Administration (FDA) has responsibility for assuring that drugs are effective and safe before being offered to the public). So Gaucher patients in the rest of the world will necessarily wait for the US regulatory process to run its course.

The Genzyme projection is that the Allston facility will be running at full certified production by the end of this year, 1996, with every treated Gaucher patient receiving Cerezyme (instead of Ceredase) by January 1997. Bear in mind that this is not an official promise by me or anyone else. I'm just reporting on what I was told today.

Editor writes: This may happen for US patients but we hear that European registration of Cerezyme will not occur until at least early 1998. However some patients may obtain it earlier on a named patient basis in a similar way that some received Ceredase before it was registered in the UK.

Return to contents page

Source: Gauchers News September 1996

© Copyright Gauchers Association 1996