Genzyme gets slapped on the wrist by FDA
Genzyme to warn it about manufacturing issues at its
biomanufacturing facility in Lyon, France.
In the letter, dated 19 September but made public on Tuesday, the regulator said that during an inspection in June inspectors found "significant deviations" from current good manufacturing practices (cGMP) in the production of Thymoglobulin (anti-thymocyte globulin [rabbit]), an antibody-based drug used in kidney transplant patients. According to the letter, Massachusetts-based Genzyme had issues with its purified water system and quality control unit at the biologics facility located in Marcy L'Etoile in Lyon, which could lead to impurities in the product if the company did not take action. The FDA letter follows a Form 483 issued to Genzyme in June which described the safety problems found during the manufacture of Thymoglobulina bulk lots that are used to formulate the drug. Genzyme responded to inspection's observations but the FDA said the response "did not provide sufficient detail to fully assess the adequacy of the corrective actions". The agency urged Genzyme to take prompt action to correct the problems and gave the biotech firm 15 days to do so, or it could face licence suspension or revocation. Genzyme announced in June it would build a new €105m biomanufacturing plant in Lyon for the production of Thymoglobulin as it anticipated a high demand for the drug in the long term. The new 140,000-square-foot facility in Lyon is expected to replace Genzyme's smaller plant in nearby Marcy l'Etoile and will provide more than twice the manufacturing capacity. Construction is expected to start later this year, and will only be up an running in 2011. Approximately 165 people are employed at the existing Thymoglobulin plant, and Genzyme expects that approximately 50 new jobs will be created when the new facility operates at full capacity. Sales of the drug totalled $149.5m (€105.6m) last year, an increase of 17 per cent compared with the previous year. The product is currently approved in more than 50 countries for various indications, including the treatment and the prevention of acute rejection of solid organ transplants. The firm operates 15 GMP manufacturing facilities worldwide, of which seven are in Europe. Genzyme was unavailable for comment at the time of publishing.
