The Ireland-headquartered drugmaker began the recall last Friday, explaining that it decided to pull one batch of the drug – velaglucerase alfa – after visible particulates were detected in some of the vials used to store the injectable.
Subsequent investigation revealed that the particulates were pieces of stainless steel and barium sulphate which – according to Shire – are present as a result of product fill-finish conducted by an unnamed third-party supplier.
A Shire spokeswoman told Outsourcing-pharma.com that: “We are not providing the name of the third-party” adding that the firm “takes full responsibility for its manufacturing processes.”
She also said that it would not be switching fill finish supplier and said that “Shire has taken corrective and preventative actions to prevent reoccurrence.”
Shire makes VPRIV at its facilities in Alewife and Lexington in Massachusetts, the latter of which was approved to produce the drug by the US Food and Drug Administration (FDA) just last month.
At the time CEO of the National Gaucher Foundation Rhonda Buyers said the new plant – which is also cleared for VPRIV production by the European Medicines Agency (EMA) – “provides greater assurance that Gaucher patients will receive consistent and uninterrupted access” to the drug.
VPRIV came to prominence in 2009 when Shire was one of two Gaucher’s disease drug manufacturers – the other being Protalix – given dispensation to make its treatment while market leader Genzyme worked to fix production problems at its plant in Allston.
The firm’s spokeswoman told us that: “Shire has significant quantities of VPRIV to replace any affected product. Shire does not anticipate any disruption in supply as a result of this voluntary recall.”