New Pharmaceutical Stability Study Capability Launched in Europe

23rd June  2008, 0800 – United Kingdom

A new Intertek pharmaceutical stability storage facility was formally launched on June 19th offering expanded and improved storage stability services. The facility, located in Manchester, UK, will provide stability storage studies for pharmaceutical products and also complex pharmaceutical and biopharmaceutical products.  The facility is fully integrated with the advanced analytical capability and technology of the Intertek ASG GLP/cGMP laboratory. Applications include:

• low solubility drugs where the need for highly sensitive assays drives the application of techniques such as LCMS, GCMS and ICPMS
• characterization any unknown impurities should any unanticipated impurities become apparent during stability trials.
• biopharmaceuticals where advanced techniques are needed to probe areas such as post translational modifications, secondary structure and aggregation status.
• comparator study and extractables / leachables study requirements. These types of studies also require stability storage and can be relatively complex, requiring characterization and method development / validation expertise.
• Stability studies on sophisticated drug delivery systems and complex formulations

The facility was launched during a seminar event held at the Intertek ASG facility. Nick Crabb, PhD, Laboratory Director, Intertek ASG, introduced the facility to invited customers and colleagues from the pharmaceutical industry. This was followed by Intertek’s Stability Study Expert, David Browne, delivered a presentation entitled "Guide to Outsourcing Stability Studies’.

The new service is a significant addition to the current Intertek stability storage facilities located in New Jersey, USA and Melbourne, Australia both of which include major pharmaceutical companies amongst their clients.

If you would like to find out more about the new facility or the Intertek pharmaceutical analysis capabilities then please contact pharma-europe@intertek.com for an information pack.