SCIEX

Articles

A Deep Dive into the Characterization of a Complex cIEF Electropherogram from an ADC Using a Novel Integrated icIEF-UV/MS System

Charge heterogeneity is present in most biopharmaceutical protein products. During the manufacturing process, charge heterogeneity of the protein therapeutics can occur due to enzymatic cleavage and chemical post-translational modifications (PTM). For therapeutics like ADCs, not only the antibody contributes to the heterogeneity but also the linker and payload, which add even more complexity to the charge variant profiles. Characterizing the charge heterogeneity of ADCs is essential for critical quality attribute (CQA) assessment to ensure drug safety, efficacy, and potency.

mAb Characterization Process Innovations

Earlier assessment of molecules provides valuable insights into the manufacturing developability of molecules, reducing the need for unnecessary experimentation. The Intabio ZT system has the potential to make in-depth characterization of biopharmaceutical product charge variants quicker and more efficient to meet demanding timelines during early-phase clinical development.

True High-Throughput Bioanalysis

Rapid sample analysis using AEMS technology improves bioanalytical study turnaround