Hospira helps Genzyme tackle manufacturing problems
pharmafile | January 6, 2010 | News story | Manufacturing and Production |Â Â Cerezyme, Fabrazyme, Genzyme, HospiraÂ
Genzyme has taken the decision to move the fill and finish stages of its manufacturing process to Hospira in order to accelerate its recovery from the production issues that have dogged it in recent months.
Contract manufacturer Hospira will carry out the final stage of manufacturing for a number of Genzyme’s products, including Gaucher disease treatment Cerezyme (imiglucerase) and Fabry disease drug Fabrazyme (agalsidase beta) which have been in short supply as a result of manufacturing problems at the firm’s Allston Landing plant.
Genzyme faced two major challenges at its manufacturing facility in Allston Landing last year, relating to regulatory compliance issues and an unrelated problem with a viral contaminant in the facilities bioreactors that forced a shutdown for several weeks.
Management at the company has since conceded that the problems at the plant came from the added pressure of asking it to also produce Myozyme (alglucosidase alpha), a treatment for Pompe disease. Manufacturing of Myozyme has since been transferred to Genzyme’s production plant in Belgium.
In addition to Cerezyme and Fabrazyme, Hospira will also provide fill and finish services for Myozyme and Thyrogen (thyrotropin alfa) a product for detecting residual thyroid cancer. The two companies have estimated the transfer of technologies will take several months to complete.
In November, the US Food and Drug Administration issued a notice warning of the potential for contamination with foreign particles such as rubber and stainless steel fragments in Thyrogen and another products, (laronidase) for mucopolysaccharidosis type I. The transfer to Hospira will allow Genzyme to replace and upgrade the equipment at Allston Landing.
The agreement with Hospira expires on December 31, 2015, in the first instance but can be extended for additional terms of two years as required. The deal is also dependent on Hospira’s manufacturing facility receiving regulatory approvals.
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