SGS is pleased to announce the opening of its cell-based assay lab at its facility in Poitiers, France.
With the launch of these new services, SGS has already initiated two projects involving Neutralizing Antibody (NAb) assays for a large pharmaceutical client with other projects being set up. To support the growing pipeline of bioassay requests, SGS has already installed and validated two of the latest generation BD Flow Cytometry Systems. The FACS System and upgraded software (FACS Suite) are suited for clinical trial samples, have barcode capability and use a diversity of tube/plates formats. The software is 21 CFR Part 11 compliant and the low data variability with automated processes allows for easy data comparison in multicenter clinical trials.
“With this new equipment and staff, we now have all the necessary expertise to deliver these sought-after bioassay services to meet the needs of our clients,” said Rabia Hidi, Director Biomarkers & Biopharmaceutical Testing. This new service offering complements the 500 square meter (5,400 square feet) biological assays expansion undertaken in October 2010.
Since the lab’s opening, SGS has established a collaboration with a local Blood Transfusion Center in Poitiers, allowing access to blood samples within one hour. This collaboration allows SGS to validate methods using fresh blood and determine the stability of relevant markers of blood cells from very early time periods after blood collection. Should the stability of the samples not allow for shipping, SGS can dispatch scientists to the clinical trial’s sample collection site to perform the bioassay analyses nearby or even onsite.
“What is interesting to note are the number of requests for services in support of biosimilar development,” states Anne Hays, Executive Vice President SGS Life Science Services. “We have become a one-stop-shop for biopharmaceutical and biosimilar analysis; working with our SGS M-Scan laboratories to provide protein and peptide characterization services and our lab in Poitiers which now has the expertise to run comparability studies using both cell-based and immunoassay analyses.”
With 19 laboratories offering contract analytical and bioanalytical services, SGS leverages its strong global network to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I-IV clinical trial management and services encompassing clinical pharmacology studies, data management, pharmacovigilance and regulatory consultancy.
Global Marketing Director
Life Science Services
SGS, 75 Passaic Avenue, Fairfield, NJ 07004, USA
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 70,000 employees, SGS operates a network of over 1,350 offices and laboratories around the world.