Biosafety Testing

In 2012, SGS acquired Vitrology in order to provide a comprehensive range of biosafety services for biologics, including: virology, cell and molecular biology as well as microbiology and electron microscopy. Health Authorities, including the US FDA and the EMA, require biopharmaceuticals to undergo safety testing to demonstrate that all cell banks, viral banks, raw materials of animal origin, bulk harvests, and batches of clinical drug are free of bacteria, fungi, mycoplasma, viruses and other potential contaminants such as endotoxins.

SGS supports clients by ensuring product safety in satisfying these regulatory requirements through a large range of validated assays and develops new services in the following areas:

- Cell bank and virus seed characterization per the major compendia, regulatory and ICH guidelines.
- Raw material, bulk harvest testing and finished products testing (sterility, endotoxin, mycoplasma, viruses and other potential biological contaminants)
- Final product testing for residual DNA and other process related impurities
- Formulation and stability studies
- Regulatory and safety consultancy services
- Custom development of assays

In order to facilitate access to these services, SGS operates a Sample Processing Center from its Life Sciences facility in Lincolnshire, IL, just outside of Chicago. This logistic platform, with Biosafety Level 2 capabilities, serves as a centralized receiving point for North American clients with biologics samples for virus testing and related biologics assays.