SGS, a leading bio/pharmaceutical, analytical and bioanalytical contract solutions provider, has made additional investments at its laboratory in Fairfield (NJ, USA) to increase services and capacity in support of extractables and leachables (E&L) testing within the pharmaceutical and related industries.
At this North American Center of Excellence for E&L, two additional, state-of-the-art instruments have been installed and validated, and hiring is currently underway for additional analysts, who will be dedicated to these services.
The new instruments, an LC-MS/MS, and GC-MS with head-space capability, are both high resolution and high throughput systems, allowing for improved and rapid identification of trace unknown extractable compounds.
The laboratory currently offers testing facilities for a wide range of E&L applications, including final pharmaceutical packaging, single-use systems and medical devices.
“SGS has seen a rise in the demand for services in this area, and we have invested significantly across our global network to ensure that we can maintain our strong reputation for extractables and leachables testing expertise,” commented Kelly Bertrand, General Manager of SGS’s Fairfield facility. “The additional capabilities we have now at Fairfield allow us to overcome greater analytical challenges for our existing clients, and ensure we can remain competitive and have the capacity to attract new customers.”
This E&L investment at the Fairfield laboratory follows the announcements in 2016 of the introduction of comprehensive drug compatibility study testing at its Shanghai laboratory in China, and the opening of a new global Center of Excellence for Extractable Studies and Impurities Profiling in Wiesbaden, Germany.
With 21 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly owned global network, present in North America, Europe, and Asia, to deliver harmonised solutions to large pharmaceutical and biotechnology firms.
In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I-IV clinical trial management, and services encompassing data management and statistics, PK/PD modelling and simulation, pharmacovigilance and regulatory consultancy.