FDA & EMA plant approvals to cut bottlenecks at Genzyme

Approval by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) will allow Genzyme to transfer production of Fabrazyme (agalsidase beta) to its Framingham plant. This move will free up capacity at Allston Landing and, Genzyme hopes, cut the bottlenecks it now faces.

“By moving Fabrazyme over to Framingham, we can eliminate some of those bottlenecks and therefore increase the output, even though we’re not necessarily increasing the number of bioreactors​”, Chris Viehbacher, CEO of Sanofi, Genzyme’s parent company, said in November.

Bottlenecks stem from using the Allston Landing, Massachusetts production site, which faced quality problems in recent years, to manufacture multiple drugs. Allston was designed to manufacture one product, Viehbacher said, and returning to this model will streamline the purification process.

By realising these gains Genzyme will move closer to ending the Fabrazyme shortage. The most severely affected European patients will return to full dosing in the first quarter, Genzyme said, and the move to return everyone currently receiving Fabrazyme in the US to full doses will also begin.

Longer-term gains​

In the longer-term the move will also help Genzyme boost production of Cerezyme (imiglucerase for injection). Moving Fabrazyme production away from Allston frees up two of the six bioreactors for use in manufacturing Cerezyme but work is needed to make the switch.

“In order to convert those to Cerezyme, there has to be some change in equipment, and there has to also be certain regulatory approval. So, an actual increase in bioreactor capacity is unlikely to occur in 2012​”, Viehbacher said.

Further gains could also be achieved as Genzyme progresses under its FDA consent decree. Working under the consent decree doubled lot release times, as Genzyme and a consultant are both doing quality assurance, but over time this process could be shortened.

“Generally what happens is, as you make progress in the site and confidence develops, you can start moving to doing some of these activities in parallel rather than in sequence. And then we probably, just even with that, get back to the volume we need on Cerezyme​”, Viehbacher said.