Intertek Commission Expanded and Improved Stability Study Capability for Complex Products

14 April 2008, 0800 – United Kingdom

A new pharmaceutical stability storage facility has been commissioned by Intertek offering expanded and improved storage stability services. The facility, located in Manchester, UK, will provide stability storage studies for complex pharmaceutical products fully integrated with 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. This facility is also ideally suited for biopharmaceuticals where advanced techniques are needed to probe areas such as post translational modifications, secondary structure and aggregation status.

Nick Crabb, PhD, Laboratory Director, Intertek ASG, said “In combination with the established advanced analytical capability of the Intertek ASG laboratory, this new facility now enables Intertek to provide leading stability storage services for complex medicines to pharmaceutical companies in Europe.”

The facility will also benefit clients with 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.

The new service will be launched in June 2008 and will be a significant addition to the current Intertek stability storage facilities located in New Jersey, USA and Melbourne, Australia both of which include major pharma companies amongst their clients.

Significant expansion and investments for Intertek Pharmaceutical Services within the past 12 months include; acquisition of BioClin Research laboratories, Athlone, Ireland, substantial expansion of the Intertek LC-MS bioanalysis capacity in Sacramento and new characterisation and isolation capabilities for impurities in protein therapeutic products (Manchester).

In addition to the core pharmaceutical services locations, Intertek also boasts an extensive network of advanced analytical services and R&D facilities serving a wide range of industries which enable Intertek to provide an unrivalled analytical service package. Intertek Pharmaceutical Services is now able to offer access to approximately 300 scientists and expert technical staff working within the pharmaceutical regulatory environment.