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SGS Life Science Services, the leading bio/pharmaceutical analytical and bioanalytical contract solutions provider, today announced that it has installed and validated instrumentation which uses frequency modulation spectroscopy (FMS) for headspace oxygen analysis of biopharmaceutical container closure systems, as well as imaged capillary isoelectric focusing (icIEF) for analysis of charge distribution and heterogeneity in biopharmaceuticals, at its facility in Mississauga, Canada.
FMS now forms part of SGS’s comprehensive package and container testing services, and has the advantage over traditional methods, which use dye ingress to monitor fractures within biopharmaceutical packaging, in that the test is non-destructive, reduces the variability of analysis and conserves valuable product for further testing. Oxygen detection is a more sensitive analysis method and is reproducible on fractures less than 10 microns in size, which limit dye-based testing.
icIEF analysis has become a key technology at the facility for determination of the charge distribution across biopharmaceutical molecules, lending additional versatility to the already strong, multi-platform capillary electrophoresis service offering. The test, which is vital for establishing charge heterogeneity during lot release and stability testing of biopharmaceuticals, is more sensitive than traditional slab gel IEF, and often provides superior resolution over traditional mobilizing icIEF or chromatographic charge profiling. It also allows more challenging samples, which are potentially difficult to focus or resolve to be analyzed, while dramatically reducing development times.
“By investing in these new services, we have the capability to provide clients with faster, more accurate results, while protecting the integrity of the supply chains of valuable biopharmaceuticals,” commented Michael Lindsay, Vice President Life Science Services, SGS Canada. “As a company, SGS is committed to investment in new technologies that benefit not only our clients directly, but also patient safety as a whole.”
With 18 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides clinical trial management (Phase I to IV), and services encompassing data management and statistics, PK/PD modelling and simulation, pharmacovigilance and regulatory consultancy.
