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.
Analyze Charge Variants in Antibody-Based Therapeutics Using Cation Exchange Chromatography
July 18th 2024This application note discusses the latest development on high performance cation exchange bio-separation columns for determining charge variants in protein-based biotherapeutics, as well as the strategy on method development.
The Power of HPLC/SFC Control and AQbD in One Software
July 17th 2024Download this infographic for a quick overview of Shimadzu’s LabSolutions Method Development (MD) software, an effective and automated software solution for U/HPLC method development that uses analytical quality by design (AQbD) principles in its workflow.
