Simple to use assays generate accurate, robust and reproducible results to accelerate the process of demonstrating biosimilarity and the development of lot release assays for drug candidates
SGS, a bio/pharmaceutical analytical and bioanalytical contract solutions provider, has entered into a collaboration with DiscoverX, a 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 the 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 during 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 neutralising-antibody assays.
‘These assays are simple to use and generate accurate, robust and reproducible results that 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 biocomparability and the lot release testing of biosimilar drugs. These assays are available to our clients to use as a product; 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.’