BioOutsource facility passes US FDA inspection

By Gareth Macdonald contact

- Last updated on GMT

BioOutsource passes US FDA inspection (source: iStock/IvelinRadkov)
BioOutsource passes US FDA inspection (source: iStock/IvelinRadkov)

Related tags: Sartorius stedim biotech, Food and drug administration

A laboratory operated by recent Sartorius Stedim Biotech (SSB) acquisition BioOutsoruce has passed a GMP inspection by the US FDA.

The facility in Glasgow, Scotland – which provides analytical services that support the testing of biologics, vaccines and biosimilars – was visited by US Food and Drug Administration (FDA) inspectors in January.

BioOutsource CEO, Gerry MacKay told us “generally speaking, passing the FDA inspection in terms of the biologics market is a major accomplishment for us."

He added that: “Having our quality systems and analytical services certified is a big step towards welcoming new business from the US market​.” 

The facility passed an inspection by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 2015 and – according to BioOutsource – has received similar positive reports from numerous biopharma clients.

BioOutsource​ was bought by SSB a year ago, which told us the Scotland-based services firm’s service portfolio had prompted the acquisition.

A few months later SSB increased its earnings guidance citing the contribution made by BioOutsource and its other recent acquisition Cellca​ as drivers for the revision.

Earlier this month SSB's parent company Sartorius reported that its bioprocess solutions division generated revenue of €809.2m ($887m) in 2015, an increase 20.9% on the previous year.

The firm said combined BioOutsource and Cellca had "contributed nearly two percentage points in constant currencies to the division's sales expansion​."

Related topics: Markets & Regulations

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