Genzyme est prête pour une ré-inspection par la FDA 3/08/2009

Article classé dans la catégorie : "NOUVELLES des LABORATOIRES".

Vous trouverez des liens utiles à la suite de la rubrique "CATEGORIE".

Ghislaine SURREL

maladies-lysosomales-subscribe@yahoogroupes.fr

Genzyme Ready for Re-Inspection, Shares Tips With Industry 439 words

3 August 2009 Orug Industry Oaily ORIOY

Vol. 8, No. 149 English

Copyright (c) 2009 Washington Business Information, Inc.

Genzyme is working with the FOA to schedule a re-inspection of its Allston, Mass., manufacturing facility to assess corrective actions after a February warning letter and a recent virus-related shutdown.

The warning letter sa ys the company did not update its computerized manufacturing system for Fabrazyme (agalsidase beta), a treatment for Fabry's disease, and ran an aseptic filling line at an unvalidated line speed (DIO, March 11). Inspectors visiting the plant in May found that Genzyme had not adequately implemented corrective actions, according to a July 30 letter to the company.

The FOA will assess those co!rective actions again, the company says in a statement las! week. The agency also will review Genzyme's remediation efforts after the recent identification of a virus caused the company to suspend production at the plant (DIO, June 17).

The sanitizing of the facility is complete, and production of Fabrazyme and Cerezyme (imiglucerase) for Gaucher disease has resumed, Genzyme says.

Standard Test Oidn't Work

The viral strain involved in the contamination, Vesivirus 2117, is a very real concern for industry, Mark Bamforth. Genzyme senior vice president of corporate operations. told DIO. Bamforth is overseeing the Allston sanitation.

'We felt we had quite a lot of protection in place, and yet here's a virus that got under the radar screen and did not show up in the industry-standard viral test," he said.

Bamforth sa id Genzyme has received advice from other companies on decontamination and prevention ­for example, on how to make a more sensitive assay to test for the virus. Companies also recommended Genzyme use a high-temperature, short-time process to sterilize media and avoid heat damage, he said.

Genzyme plans to begin using the specific virus-detection assay during processing, in addition to using it at the raw materials stage. This will help the company detect the virus if it is present in low enough levels to pass through the raw materials screening, Bamforth said. The company also removed pipe insulation in case it might harbor the virus.

Genzyme hopes the assay and tips from its experience will be widely available to industry. and it will present its findings at industry meetings, Bamforth said. "We're also looking to publish the scientific information and we're working with a company involved in providing these kinds of tests for the industry."

Genzyme's staff of about 500 at the facility were involved in cleaning and preparing areas, and the company enlisted specialist cleaning companies and contractors for procedures su ch as equipment disassembly. -­April HoUis

Release date: Aug. 3, 2009