The laboratory will be equipped with a number of state-of-the-art instruments, to respond to the growing need for biopharmaceutical studies during the early and late phase of characterization, as required by the ICH guidelines.
Due to open by the end of Q3 2018, the new laboratory will complement the existing 800m2 facility and offer the new services for high order structure analysis of biologics, including circular dichroism (CD), Fourier-transform infrared spectroscopy (FTIR), extrinsic and intrinsic fluorescence, analytical ultracentrifugation (SV-AUC), size exclusion chromatography with multi-angle light scattering (SEC-MALS), dynamic light scattering (DLS) and differential scanning calorimetry (DSC).
"To fulfil regulatory requirements, the biopharmaceutical industry increasingly expects its contract service providers to offer comprehensive characterization capabilities from a single location," said Luc-Alain Savoy, Managing Director SGS Life Sciences Geneva. "SGS is committed to investing in its network of laboratories to offer integrated solutions and adapt to its clients' local and global needs."
When complete, the new laboratory will enable the Geneva facility – which opened in 1991 and is cGMP certified, GLP compliant and FDA inspected – to offer a full ICH Q6B physico-chemical characterization of biological products.
With 19 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the biopharmaceutical market, SGS also provides Phase I-IV clinical trial management, and services encompassing data management and statistics, PK/PD (pharmacokinetic/pharmacodynamic) modeling and simulation, pharmacovigilance and regulatory consultancy.
For further information, please contact:
Global Head of Marketing, Life Sciences
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SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 95,000 employees, SGS operates a network of over 2,400 offices and laboratories around the world.