Conjugate 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