SGS and DiscoverX to collaborate on the qualification and supply of bioassays for biopharmaceutical development

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.

DiscoverX has developed ready-to-use bioassays for a number of biologic drugs that are set to lose patent protection over the next 10 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.