DiscoverX supplies cell-based assays and services for drug discovery and development. As part of this agreement the two companies will work together to provide simple and qualified assays for functional comparability, for use in quality control, lot release and stability testing of biosimilars and biobetters.

DiscoverX already has more than 35 ready-to-go bioassays for biosimilars and biobetters. These include popular targets, such as bevacizumab, cetuximab, insulin and ranibizumab, and also include a number of biologicals that are set to lose patent protection over the next 10 years [1]. 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’, according to Dr Fiona Greer, Global Director, Biopharma Services Development at SGS.

Reference
1. Derbyshire M. Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040

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