Brian Rivera | Authors


High-Flow Weak Cation Exchange for Charge Variant Analysis

Within the broad scope of analytical techniques required to characterize a protein, chromatographic methods have shifted towards high-flow analyses that can drop development time significantly. However, fast analytical methods for charge heterogeneity have lagged in development because current column technologies are ultrahigh-pressure liquid chromatography (UHPLC)-incompatible. This article will demonstrate the development of a high-flow method for charge variant analysis made possible through a bioinert titanium column flow path.

Addressing the Challenges of Drug-to-Antibody Measurement

Antibody–drug conjugates (ADC) are an emerging pharmaceutical technology, with the potential of being the true “magic bullet”. However, these inherently complex biomolecules have unique analytical challenges. One is the determination of the drug-to-antibody ratio (DAR). The average DAR and the drug distribution need to be monitored and could determine the success of an ADC. This article discusses the chromatographic methods used to determine DAR, including hydrophobic interaction chromatography (HIC), reversed phase, and liquid chromatography–mass spectrometry (LC–MS).