SGS Life Science Services, the leading pharmaceutical analytical and bioanalytical contract solutions provider, today announced that it has acquired a Cobas 6000 Analyzer System, Chemistry Module, for use at its Poitiers, France, laboratory, further underlining its commitment to supporting the development of new biological products. This platform allows the determination of a large number of biological parameters (biomarkers) and metabolites, in as little as two minutes, with precision, and reliability, using very small sample volumes.
Employing the concept of "open" technology, the Cobas 6000 provides for easy-to-use reagents as well as those not provided by the manufacturer. This promotes the optimization of protocols and allows SGS to offer additional tests that can be validated based upon the company’s expertise. In order to meet the requirements of bioanalytical Good Laboratory Practice (GLP), all results are entered directly into the Watson Laboratory Information Management System (LIMS) for traceability of analysis and can be grouped by patient, even if the results are obtained during long term kinetics.
"This investment will permit the SGS Poitiers site to provide more analysis of biomarkers in a GLP environment and complies with the latest guidelines of Good Clinical Practice (GCP)," said Alain Renoux, Director of SGS Life Science Services, Poitiers. "From a clinical protocol compliance perspective, the Cobas 6000 System ensures traceability of the sample before and after dosing, and allows trial sponsors to limit the volume of biological matrix collected in the patient."
This latest investment to support biological product manufacturers complements developments at the SGS Life Science Services laboratory in Clichy, France, where the qualification of a new Hitachi L-8900 Amino Acid Analyzer has recently been completed. This instrument is used to perform the analysis of amino acids in compliance with pharmacopoeial requirements (EP Section 2.2.56 and USP <1052>). Both Life Science Service laboratories in France offer a full range of tests in accordance with Good Manufacturing Practices (GMP), GCP and GLP for the development of small and large molecules (innovative products, generics, or biosimilars).
With 21 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned 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, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.
For further information, please contact:
Ferdinand Dabu Richard Kerns
Global Marketing Director President
Life Science Services NEPR
SGS Manchester, UK
Fairfield, USA Tel. +44 (0)161 728 5880
Tel: +1-973-287-1219 Email: firstname.lastname@example.org