cphi-onlineAugust 29, 2018
Tag: ICH , GMP , Biopharmaceutical
SGS is expanding its biopharmaceutical testing capabilities in Geneva, Switzerland with a new 200-m2 laboratory. 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 800-m2 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.
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