The facility in Royston near Cambridge, UK houses capacity for stability testing for small molecule and biopharmaceutical drugs and medical devices. The site will operate as part of Intertek’s network, which includes sites in Manchester, New Jersey in the US and Melbourne, Australia.
Intertek told us “The drive for the new GMP stability facility is primarily client demand for both stability storage and stability programs that include testing” adding that it will provide capacity for bespoke tests like risk management and use/misuse studies.
The firm added that “The sheer volume of the new expansion allows us to store bulkier or larger products such as some medical devices. These can take up a lot or room in a stability chamber.”
The Cambridge site – which Intertek acquired along with Melbourn in 2013 – has provided stability testing services to the pharmaceutical and medical devices sectors for more than 20 years for drugs for a range of conditions according to Intertek.
“Our expertise for drug stability includes areas of specialism such as inhaled products behind treatments for Asthma, Cystic Fibrosis, Diabetes, and Chronic Obstructive Pulmonary disease and biologics such as monoclonal antibodies, proteins and antibody drug conjugates.”
In addition to regulated pharmaceuticals and biologics, the new stability site will also house testing services for ‘nutraceuticals,’ which include things like vitamins, nutritional supplements, herbal remedies and so called functional foods.
The firm told us that demand for such products was also a factor, explaining that “There is also a demand for stability testing for nutraceuticals and functional foods and the increased capacity will allow a much wider service provision than before.”