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The companies will provide assays for functional comparability, for use in quality control, lot release, and stability testing of biosimilars and biobetters.
SGS, a biopharmaceutical, analytical, and bioanalytical contract solutions provider, entered into a collaboration with DiscoverX, a life-science company that supplies cell-based assays and services for drug discovery and development, according to a March 30, 2016 press announcement. Under the terms of the agreement, SGS and DiscoverX will provide assays for functional comparability, for use in quality control, lot release, and stability testing of biosimilars and biobetters.
According to SGS, DiscoverX has developed 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 or good clinical practice environment.
SGS notes data on the first assay qualification studies will be presented at the CASSS Bioassays 2016 Conference in Silver Spring, MD from April 4-5, 2016. SGS says they will offer the functional comparability assay services to clients under GMP/GCP from its Poitiers, France laboratory.