In the 26 years of Zoladex manufacture, AstraZeneca’s Macclesfield, UK, facility has been home to four plants used exclusively in its manufacture. Two have been retired and two are still in operation, but the Pharma Giant announced this week it was investing £120m into a fifth facility after receiving planning approval in September.
Site manager Tony Broughton was able to confirm to in-Pharmatechnologist.com the new 6,668m2 plant would be used solely for Zoladex and would be a “replacement asset,” allowing one of the current facilities in Macclesfield to retire.
The drug is used to treat patients with prostate cancer by administering a subcutaneous injection of a solid state depot that dissolves in the body over three months, Broughton said, and thus the manufacture is a “difficult, complex, multi-stage process which - though refined over the years - is still fairly manual.”
The product’s uniqueness is partly due to such difficulty in manufacturing, and therefore he added: it is “not a product we would take a risk with by outsourcing.”
Zoladex is a topseller for AstraZeneca with sales of $1.09bn for 2012, according to the firm’s annual report, and is approved in 120 countries for the treatment of prostate cancer, breast cancer and certain benign gynaecological disorders.
Although key patents have expired, Broughton told us global sales were growing due to growth from emerging markets. Regarding a generic version, “one company tried and failed,” he said, and therefore sustained sales were a key factor to this facility investment.
Construction commences in the next few weeks and the facility is set to be completed by 2016.
According to Broughton, AstraZeneca's Macclesfield site and a facility owned by bioanalysis company Waters will form part of a renewed interest in biosciences in the region dubbed a “Northwestern Science Corridor” by a Councilor representing Cheshire East.
This will be propped by the AstraZeneca site at Alderley Park which the company announced earlier this year was to cease R&D operations as part of a restructure that would affect up to 2,500 jobs.
“There is now a task force between AstraZeneca, the local and national Government, and the scientific community to repurpose Alderley Park,” he told us. The intended biohub is “already exceeding expectations,” he continued, with plans having to accelerate to accommodate the interest at the site.
AstraZeneca will keep a presence in Alderley Park with approximately 700 staff on site, Broughton added.