Assay Development

CDMO custom development of test kits provides diagnostic companies with a structured route from an initial assay concept to a reproducible, manufacturable and commercially viable in vitro diagnostic product. Instead of outsourcing only one isolated development task, an IVD-focused CDMO program can integrate assay design, raw-material selection, reagent formulation, analytical optimization, pilot production, stability studies, manufacturing transfer and regulatory-support documentation into a coo...