Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
News|Articles|August 28, 2018
SGS Increases Biopharma Characterization Capabilities
Author(s)Pharmaceutical Technology Editors
An expansion of laboratory facilities in Geneva, Switzerland expands SGS services for high-order structure analysis.
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SGS announced on Aug. 28, 2018 that the company is expanding its biopharmaceutical testing capabilities in Geneva, Switzerland with the addition of a 200-sq.-m laboratory for early and late phase of biopharmaceutical characterization.
Scheduled to open by the end of the third quarter of 2018, the new laboratory will provide 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).
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 ICH Q6B physico-chemical characterization of biological products, the company reported in a press announcement.
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