SGS also provides Phase I-IV clinical trial management, with services including data management and statistics, PK/PD (pharmacokinetic/pharmacodynamic) modeling and simulation, pharmacovigilance, and regulatory consultancy.
The new 200 square meter laboratory, slated to open by the end of Q3 2018, will be equipped with several instruments and complements the company’s existing 800 square meter facility.
Upon completion, the laboratory will offer full ICH Q6B physico-chemical characterization of biological products.
According to SGS, the expansion responds to the “growing need for biopharmaceutical studies during the early and late phase of characterization, as required by the ICH guidelines.”
Services to be offered include 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 of SGS Life Sciences Geneva in a press release.