Bespak has commenced full-scale production of the Exubera inhaler
Bespak, a leading provider of specialty medical devices, 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 Nektar Therapeutics Inc, 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, UK, 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 35,000 square metre manufacturing environment (2,100 square metres of which is cleanroom space), compliant with all the regulatory requirements necessary to produce 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.
Mark Throdahl, Chief Executive of Bespak, said: "We are delighted that this much anticipated therapy is now almost ready for launch".
"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".
"Exubera is targeted to treat adult patients with types 1 and 2 diabetes.
It is estimated that nearly 180 million people worldwide suffer from diabetes, with that number expected to rise to 300 million by 2025.
Currently, diabetes and its complications account for healthcare costs of over US$100 billion per year in the United States alone.
