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Antibody-Drug Conjugates Development:
Analytical

Analytical characterization plays an important role in ensuring product integrity and manufacturing consistency, which are essential for demonstrating safety and efficacy to the FDA and other regulatory authorities. However, the heterogeneity of ADCs makes the analytical characterization particularly challenging. Selection of appropriate analytical techniques depends on the properties of the linker, the drug and the choice of attachment site. Wolfe Laboratories uses common analytical methods to assess the physicochemical and biophysical properties of ADCs, including mass spectrometry-based techniques, chromatographic techniques, electrophoresis, particulates analysis and hybrid techniques, as summarized in the following table.

 

Attribute

Technique

Identity

cSDS, cIEF

Purity (deamidation and half antibody levels)

RPLC, cSDS

pI/Charge Variants

cIEF, CZE, IEX

Size/Aggregation

DLS, MALS, SEC

Concentration

UV-Vis

Average DAR

UV-Vis

Potency

ELISA

Structural stability

DSC

Post-translational modifications

Peptide mapping

Identification of conjugation sites

Peptide mapping