Somru developed the following comprehensive list of bioanalytical assays to support Denosumab biosimilar development PK Assays to support Denosumab ADA Assay to support Denosumab 1. SPEAD method 2. Somru does not recommend the use of SPR method due to the sensitivity requirements of regulatory authorities and matrix effect Neutralizing Antibody Assay Cell-based Nab Assay Pharmacodynamic Assay Somru has validated antibody …
A comprehensive bioanalytical solution for Denosumab(Prolia®, Xgeva®) Read More »