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SGS expands its Clinical Pharmacology Unit in Antwerp, Belgium with a Viral Challenge Testing facility including a 12-bed, Biosafety Level 2-Q compliant, quarantine facility.
The complete quarantine facility is setup with the latest technology, including a negative pressure system, which includes individual compartments for infected volunteers. A dedicated laboratory is equipped with a flow cabinet, acid cabinet, dedicated work space and workflows to handle specific (viral) cultures, using HEPA-filtering and an airlock system. This expansion allows SGS to conduct highly specialized clinical trials, namely viral challenge studies. In order to efficiently and effectively develop and evaluate new-generation vaccines and treatments, including influenza and RSV, new approaches outside of large-scale field trials must be considered to provide early evidence of proof-of-principle in humans. This viral challenge testing facility provides the means for clients explore these new options.
“This unique, European viral challenge testing facility enhances SGS’s service offering for our clients in the fields of infectious disease and vaccine development, allowing clients a chance to improve screening and development of their compounds” said Dr. Steven Ramael, SGS Life Science Services Medical Director. “Although the model does not necessarily reflect all parameters relevant to community-acquired infection, it does provide for a carefully controlled, systematic, and efficient method in which a number of variables can be controlled or even eliminated, with the subjects continuously monitored in a sequestered environment that minimizes safety risks for infected volunteers and that protects the outside world from a possible spread of infection.”
In addition, this model enables detailed assessment of immune parameters that help in identifying immunological correlations of infection and illness. Furthermore, the sample size required to obtain meaningful results with this model is substantially lower than for community-based studies of naturally acquired infection, which can translate into large savings in the clinical development costs for new vaccines or antiviral agents.
SGS Life Science Services is a leading contract service organization providing clinical research, analytical development, biologics characterization, biosafety, and quality control testing. Delivering solutions for bio-pharmaceutical companies, SGS provides Phase I to IV clinical trial management services encompassing clinical project management and monitoring, data management, biostatistics, and regulatory consultancy.