Analytical Aspect | Techniques/Tools Used | Current Trends |
Characterization and stability of the linker | HPLC, MS, NMR | Advanced techniques such as NMR are becoming increasingly common. |
Drug-to-antibody ratio (DAR) ascertainment | LC-MS, CE, ELISA | The development of more sensitive and accurate DAR assays is a current trend. |
Evaluating the potency of the payload | Cell viability assays, ELISA, flow cytometry | Developing more sensitive and specific assays for evaluating payload potency is a current trend. |
Assessment of purity and detection of impurities | HPLC, MS, gel electrophoresis | The use of high-resolution mass spectrometry (HRMS) is becoming increasingly common. |
Stability profiling | Varies depending on the aspect of stability studied (e.g., HPLC for degradation pathways) | The development of more predictive stability models is a current trend. |
Bioanalytical assay deployment | ELISA, LC-MS, immunoassays | The development of more sensitive and specific bioanalytical assays is a current trend. |