Summary

Antibody-drug conjugates (ADCs) represent a rapidly growing

class of therapeutics undergoing clinical development. Wolfe

Laboratories provides expert analytical characterization,

which plays an important role during discovery, process

scale-up, manufacturing, and release/stability testing of

ADCs. Selection of appropriate analytical techniques

depends on the properties of the ADC linker, the drug and the

choice of attachment site.

Because ADCs are highly heterogeneous, Wolfe Laboratories

employs multiple orthogonal methods to fully characterize

them. The below figures illustrate how Wolfe utilized UV/VIS

spectroscopy, size exclusion (SE)-UPLC, dynamic light

scattering, and mass spectrometry to characterize the

average drug-to-antibody ratio (DAR), percent free drug,

aggregation state, and DAR heterogeneity of an

immunoconjugate system.

Average DAR by UV/VIS Spectroscopy

DAR Distribution by Mass Spectroscopy

Percent Free Drug and Aggregation State by SE-UPLC

H