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New instrumentation at the SGS Mississauga, Canada facility advances testing capabilities for packaging and container testing.
SGS Life Science Services has installed and validated instrumentation that 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, according to an Oct. 28, 2015 press statement.
FMS offers advantages over traditional methods of package and container testing, which use dye ingress to monitor fractures within biopharmaceutical packaging. The FMS 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, according to SGS.
icIEF analysis is used to determine the charge distribution across biopharmaceutical molecules. The test, which is used to establish charge heterogeneity during lot release and stability testing of biopharmaceuticals, is more sensitive than traditional slab gel IEF, and can provide superior resolution over traditional mobilizing icIEF or chromatographic charge profiling, SGS reports.
Source: SGS Life Science Services