SGS has opened a cell-based assay lab at its facility in Poitiers, France. SGS has also initiated two projects involving Neutralizing antibody (NAb) assays for a large pharmaceutical client with other projects to follow.
SGS has 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 and have barcode capability and use a diversity of tube/plates formats. The software is 21 CFR Part 11 compliant and, according to the company, the low data variability with automated processes allow for easy data comparison in multi-center 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 and biopharmaceutical testing at SGS.
“What is interesting to note are the number of requests for services in support of biosimilar development,” said 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.”