anonymous
Guest
anonymous
Guest
"Lonza, a Swiss contract manufacturer, is going to begin to shut down operations at a troubled biologics facility that is located in Hopkinton MA. This will eventually lead to the loss of about 250 jobs. Originally, there was no time frame for the move, but now the company is going to start the phase out in September.
Lonza has been struggling to get the facility into compliance with cGMP regulations, which has created supply problems for some clients. The plant has had cGMP problems since 2011, when it got a warning letter from FDA. That letter focused on bad batches of an API that it makes for Ontak, which is a cancer drug made by Eisai. However, it is the drugmaker Ipsen, based in France, that is reporting supply problems that are related to this plant. In the spring, it stated that they were having problems making the orphan drug Increlex because of the problems at this facility making the API. This suggests to us that Lonza has had serious problems overcoming cGMP concerns at the plant."
Lonza has been struggling to get the facility into compliance with cGMP regulations, which has created supply problems for some clients. The plant has had cGMP problems since 2011, when it got a warning letter from FDA. That letter focused on bad batches of an API that it makes for Ontak, which is a cancer drug made by Eisai. However, it is the drugmaker Ipsen, based in France, that is reporting supply problems that are related to this plant. In the spring, it stated that they were having problems making the orphan drug Increlex because of the problems at this facility making the API. This suggests to us that Lonza has had serious problems overcoming cGMP concerns at the plant."