In a June 29 update, Genzyme clarified its current production status and the impact remediation efforts are having on its ability to release product and supply the market.
The firm stated on its newly-created “Genzyme supply update” website that the Allston plant has “resumed normal operations.” However, the supply of Cerezyme and Fabrazyme in the coming months “could particularly be affected by two factors: the impact of the production disruptions originally reported in April and the effects of preparing to implement the FDA Consent Decree.” The firm explained that the conditions of the consent decree have created extra steps in the manufacturing processes that “have affected the pace of manufacturing and product release.”
Genzyme also notes that a third factor impacting Fabrazyme production is the introduction of a new working cell bank that has “not reached the targeted levels of productivity and output.”
Issues at the Allston plant surfaced in October 2008, when an agency inspection led to issuance of an FDA form 483, followed by a Warning Letter in February 2009.
The plant’s problems expanded in June 2009 when a virus that impairs cell growth was detected in one of six bioreactors. Genzyme decided to interrupt bulk production at the plant for six weeks to sanitize the facility, leading to shortages of the drugs produced there.
Six months later, in May of this year, FDA and Genzyme entered into the consent decree, which impacts the manufacture of products at that facility and sets forth specific remediation requirements (IPQ “In the News, May 28).