Bespak geared up for Exubera launch

Speciality medical device company Bespak has commenced full-scale production of the Exubera inhaler in readiness for the imminent US launch of Pfizer's inhaled insulin therapy. Exubera was launched in Germany and Ireland in May 2006.

In conjunction with US-based Nektar Therapeutics, Bespak has been developing the inhaler's manufacturing process since July 1999. Bespak moulds and assembles more than 450 million complex devices each year and the company's Milton Keynes facility is almost exclusively geared towards the high volume production of the Exubera device.

Opened in 1998, the state of the art facility provides a 35,000m² manufacturing environment, 2,100m² of which is cleanroom space. It is compliant with all the regulatory requirements necessary to pro-duce delivery devices that come directly into contact with the drug.

Bespak, which has been instrumental in the industrialisation of the delivery device, has employed its proprietary planning tool - Bespak Product Introduction Process (BPIP) to deliver the most effective mode of manufacture and ensure the most appropriate utilisation of its facilities. BPIP extends beyond the Bespak facility and ensures the quality of components supplied throughout the supply-base of more than 20 supplier companies.

The manufacturing process at Bespak brings together 30 moulded components to assemble together with 33 bought-in parts and entails a range of processes including two-shot moulding, ultrasonic welding, cropping and laser marking.

"Our track record in delivering high volumes of complex medical devices means we are fully prepared to meet the substantial demand for this product and we look forward to participating substantially in the commercial success of Exubera in the coming years," said Bespak ceo Mark Throdahl.