Genzyme is outsourcing fill and finish manufacturing of several major drugs to Hospira in response to in-house difficulties at its Allston Landing facility in Boston, Massachusetts, US.
The biotech has faced numerous difficulties at the Allston Landing plant culminating in its temporary closure last year after it was found to be contaminated with a virus.
This led to shortages of two of Genzyme’s biggest-selling products, Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta). Manufacture of these products, as well as Myozyme (alglucosidase alfa) and Thyrogen (thyrotropin alfa for injection), will now shift to other facilities.
Genzyme is transferring some production to its facility in Ireland but is also outsourcing to Hospira. The transfer to Hospira is expected to take six to eight months, over which period Genzyme will transfer technical know-how and seek US regulatory approval.
In a filing with the US Securities and Exchange Commission (SEC) Genzyme stated that the initial term of the agreement with Hospira expires on December 31, 2015. After this date the deal will be automatically extended by additional terms of two years unless it is terminated.
By moving production away from the Allston Landing facility Genzyme hopes to be able to address the problems it faced throughout 2009 by upgrading its fill and finish capabilities.
The difficulties began in April 2008 when the US Food and Drug Administration (FDA) refused to approve the version of Myozyme produced at the Allston Landing facility, despite the drug already being manufactured at Genzyme’s facility in Framingham, Massachusetts, US.
In moving production to the Allston Landing plant Genzyme scaled up from 160L bioreactors to 2000L bioreactors and the FDA ruled that this change in manufacturing practices meant it must be considered a different molecule.
Since then the Allston Landing facility has suffered a series of setbacks, including accusations of current good manufacturing practice (cGMP) deficiencies by the FDA and the temporary closure of the plant.