SGS and DiscoverX to Collaborate on the Qualification and Supply of Bioassays for Biopharmaceutical Development
SGS, a leading bio/pharmaceutical analytical and bioanalytical contract solutions provider, has entered into a collaboration with DiscoverX, an innovative life science company that supplies cell-based assays and services for drug discovery and development. Under the terms of the agreement, SGS and DiscoverX will work together to provide simple and qualified assays for functional comparability, for use in quality control (QC), lot release, and stability testing of biosimilars and biobetters, offering products as well as services.
DiscoverX has developed ready-to-use bioassays for a number of biologic drugs that are set to lose patent protection over the next ten years. SGS has initiated the evaluation and qualification of these assays and plans to offer these as a service within a Good Manufacturing Practice (GMP) or Good Clinical Practice (GCP) environment for clients. The availability of commercial ready-to-assay cryopreserved cells in a qualified kit will remove the need for developers to employ challenging and time-consuming method development procedures, and enable them to rapidly advance to qualification and assay validation for potency and neutralizing-antibody assays.
“These assays are simple to use and generate accurate, robust and reproducible results which can accelerate the process of demonstrating biosimilarity, and the development of lot release assays for drug candidates,” commented Fiona Greer, Global Director, Biopharma Services Development at SGS. “By combining SGS’s vast knowledge in bioanalysis with the experience DiscoverX has in developing innovative cell-based assays, this collaboration will bring value to clients of both companies.”
“DiscoverX has developed industry-leading cell-based assays for bio-comparability and lot release testing of biosimilar drugs. These assays are available to our clients to use as a product and now, partnering with SGS allows us to offer these assays as GMP and GCP services as well,” said Dr. Todd Nelson, CEO of DiscoverX. Dr. Nelson continued, “This partnership will provide simple, qualified, fit-for-purpose bioassays for QC lot release and stability testing of biosimilars and biobetters to clients globally.”
Data on the first assay qualification studies will be presented at the CASSS Bioassays 2016 Conference in Silver Spring, MD. SGS will offer the functional comparability assay services to clients under GMP/GCP from its Poitiers, France laboratory. This new service will be supported by SGS’s existing characterization and analytical capabilities across its global network.
With 20 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 Phase I-IV clinical trial management, and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.
DiscoverX Corporation, headquartered in Fremont, CA, USA, is a leader in the design, manufacture and sale of biochemical and cell-based assays for the drug discovery & life science markets. This industry-leading portfolio of products and services, under the KINOMEscan®, PathHunter® and BioMAP® brands, are used to aid life science research and enable rapid development of safe and effective biologic and small molecule drugs, by improving research productivity, effectiveness of screening, lead optimization & bioanalytical campaigns, as well as providing predictive tools that deliver physiologically relevant insights on drug molecules from early discovery through pre-clinical development. DiscoverX embodies a pioneering approach to creating life science tools that have been widely adopted across the globe in pharmaceutical, biotechnology and academic laboratories. Learn more at discoverx.com.
For further information, please contact:
Life Sciences – Global Marketing Director
Agriculture, Food and Life
SGS, 75 Passaic Avenue, Fairfield, NJ 07004, USA
t: +44 (0)161 728 5880
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 85,000 employees, SGS operates a network of over 1,800 offices and laboratories around the world.