Last month, SGS Life Science Services announced its investment to develop integrated formulation and stability testing services in the UK for biopharmaceuticals. Formulation involves selection of non-active ingredients to be used in the preparation of the product and include factors that will influence stability and solubility of the final drug product. Whereas stability testing studies are performed in order to validate the integrity of the final drug product under various, defined conditions. These two new services enhance SGS’s present capability to provide high-end, characterisation-based analytical testing required of all biologics prior to market release and post marketing surveillance.
The new services will be offered from a dedicated suite in its SGS M-Scan facility, Wokingham, UK and slated to be fully operational by early Q4, 2013. The new suite will include a temperature and access controlled room for the stability units, a large separate instrumentation and wet laboratory, and cover 1,100 square feet. These new services leverage and extend SGS’s formulation and stability services currently provided from its facility in Lincolnshire, IL, US, and stability testing services from its Center of Excellence in Berlin, Germany.
“Customers require preparation and testing of their samples at one site. Sample shipment involved in multisite testing is not ideal because of the potential effects that shipping may have on sample integrity”, said Andrew Reason, Group Manager, SGS M-Scan Europe. “These studies are also an iterative process whereby data is fed back to the formulation scientists prior to generation of further samples for testing.”
Furthermore, according to Anne Hays, Executive Vice President, SGS Life Science Services, “There is an increasing trend for biologics manufacturers to outsource testing of their products and SGS strives to provide new services in response to the market’s needs in a timely manner.”
With 19 laboratories offering contract analytical and bioanalytical services, SGS leverages its strong 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, pharmacovigilance and regulatory consultancy.