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.