CDMO for IVD Raw Materials: From Antibody and Antigen Development to Scalable Diagnostic Manufacturing
The performance of an in vitro diagnostic assay often begins long before the test kit reaches the manufacturing line. It begins with its IVD raw materials. Antibodies determine molecular recognition. Antigens influence specificity and immune reactivity. Enzymes drive amplification and signal generation. Primers and probes determine molecular target recognition. Calibrators and controls help establish and monitor measurement performance. For this reason, CDMO for IVD raw materials is not simply a...
