SGS Life Science Services 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 is now part of SGS’s package and container testing services, and according to the company, 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, according to the company.
icIEF analysis determines the charge distribution across biopharmaceutical molecules. According to the company, 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. It also allows more challenging samples, which are potentially difficult to focus or resolve to be analyzed, and is designed to reduce 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,” said 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.”
