Mass Spectrometer Selection and Efficient DAR Verification Guide
Proving the structural homogeneity of protein therapeutics during the Downstream Process (DSP) and Analytical & Technology Test (ATT) phases is a cornerstone of Quality Control (QC). In particular, the global regulatory CMC guidelines demand more stringent physicochemical characterization data across the entirety of antibody production. Consequently, drug developers must carefully evaluate their mass spectrometer toolkits … Read more