DiscoverX has developed ready-to-use bioassays for a number of biologics that are set to lose patent protection in the next ten years. SGS has initiated the evaluation and qualification of these assays and plans to offer them as a service within a Good Manufacturing Practice (GMP) or Good Clinical Practice (GCP) environment for clients. According to the companies, the availability of commercial ready-to-assay cryopreserved cells in a qualified kit will eliminate the need for developers to employ challenging and time-consuming method development procedures, and enable them to quickly advance to qualification and assay validation for potency and neutralizing-antibody assays.
This new service will be supported by SGS’s existing characterization and analytical capabilities across its global network.
“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,” said 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, chief executive officer of DiscoverX. “This partnership will provide simple, qualified, fit-for-purpose bioassays for QC lot release and stability testing of biosimilars and biobetters to clients globally.”