Inspections of the Hopkinton, Massachusetts plant in April and May 2011 found cGMP (current good manufacturing practice) violations related to production of Ontak (denileukin diftitox), an oncology treatment marketed by Eisai.
Alleged failings detailed in the US Food and Drug Administration (FDA) warning letter cover active pharmaceutical ingredient (API) potency testing, quality and purity, and other areas of production.
Dominik Werner, head of corporate communications at Lonza, told in-PharmaTechnologist: “We are completely confident that answers to all of FDA’s questions are already available and will enable Lonza to submit a rapid and full response.”
Lonza has taken actions to correct all six observations, Werner said, and is “very confident that the issues raised by FDA in this warning letter are confined to the Hopkinton site and very largely to one particular product within that site”.
Other products
Failure to fix the problems could impact other products though. “It is our expectation that the corrections implemented to address the violations…are applied to all products currently manufactured and any products marketed in the future”, the FDA said.
Increlex (mecasermin [rDNA origin] injection), a growth failure treatment, is cited by the FDA as a product that could be affected if Lonza fails to address violations. France-based Ipsen sells Increlex.
In a statement emailed to in-PharmaTechnologist Ipsen said: “Ipsen is working with Lonza and the FDA to resolve as quickly as possible any issue that could prevent the production of Increlex at Lonza's Hopkinton site.
“As you know, none of the observations relate to the manufacturing process of Increlex, which remains robust and reliable. We are taking measures to ensure continuous supply of Increlex.”
Eisai response
For now though the focus is on Ontak. An Eisai spokesperson told in-PharmaTechnologist: “Eisai is aware that Lonza received a warning letter from FDA regarding quality system problems. Eisai is actively working closely with Lonza and the FDA to resolve this issue.”
Lonza responded to the inspectors comments in May but the FDA says the actions are insufficient. The FDA sent the warning letter on September 1. Lonza must provide the FDA with written details of its specific responses within 15 working days.