SGS, a leading bio/pharmaceutical, analytical and bioanalytical contract solutions provider, has announced that it is expanding its elemental analysis testing capabilities at its Villeneuve-la-Garenne, France, laboratory.
The site has invested in a new inductively coupled plasma mass spectrometry (ICP-MS) system in a move to address the updated ICH Q3D regulatory guidelines on elemental impurities.
The new instrument, a Thermo ICP-MS: iCAP RQ C2 – ICP-MS quadrupole analyser, offers accurate, high-throughput testing, and is currently undergoing validation. It is expected to be fully operational by the end of February 2017. The investment complements the atomic absorption spectroscopy, inductively coupled plasma optical emission spectrometry (ICP/OES) and ICP-MS systems already located at the facility.
“With this investment, SGS and its dedicated elemental impurities team are in a position to support pharmaceutical and biopharmaceutical companies through the challenges of the new regulatory guidelines,” commented Paul Beyou, General Manager of SGS’s Villeneuve-la-Garenne facility. “SGS is dedicated to offering its clients access to the very latest technology and expertise to ensure regulatory demands can be met efficiently and with no disruption to developmental timelines.”
ICH Q3D Step 4 was published in December 2014. Since then, it has required that a risk analysis be deployed for all drug products on the specified list of elements and their permitted daily exposure (PDE) limits. The guideline came into effect in June 2016 for new drug products, and existing products will have to comply by December 2017.
The 2100 square metre Villeneuve-la-Garenne laboratory was opened in June 2015 and replaced a facility in nearby Clichy. All the services offered at Clichy were transferred to the new laboratory, and additional capabilities for mycoplasma and residual DNA detection as well as amino acid analysis were added, to meet the demands of growing biopharmaceutical pipelines.
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.