SP 02 - From Size Exclusion to Hydrophobic Interaction Chromatography for Drug Analysis. New approaches and new columns
SP 02 - From Size Exclusion to Hydrophobic Interaction Chromatography for Drug Analysis. New approaches and new columns
Given the need to interface with complex instrumentation for the analytical determination of molecular weights or the new trend of combining antibodies with ADC pharmaceutical vectors, Tosoh Bioscience has introduced two new columns to meet these new field of interest. The name says it all: TSKgel HIC-ADC columns are Hydrophobic Interaction Chromatography columns designed for the analysis of antibody-drug conjugates (ADCs). Tosoh has constructed a new particle for HIC separations that achieves exceptional resolution among variably conjugated ADC variants. This new industry standard in non-porous particle technology ensures exceptional performance, efficiency, and robustness in the DAR analysis. An expanding TSKgel HIC-ADC toolbox now offers broadened selectivity for ADCs built using novel therapies and conjugation techniques. The TSKgel HIC ADC series simplifies method development, validation, and tech-transfer for DAR quantitation by enhancing DAR variant separation setting a new bar for ADC analysis. Achieve unmatched performance in DAR quantification for ADCs The most important factor in determining the Drug-Antibody-Ratio (DAR) in ADCs is maximum resolution among different payload variants. Individual DAR peak areas can then be used to calculate the average DAR. While both TSKgel HIC-ADC columns yield suitable separation profiles for DAR quantitation, the TSKgel HIC-ADC Phenyl column excels for conjugates rich in heterocyclic content. When benchmarked against other commercially available HIC columns, the TSKgel HICADC columns demonstrate superior selectivity for the separation of Phospholipase-C conjugated antibody isoform. While TSKgel HIC-ADC columns facilitate HIC-based ADC separations, additionally demonstrates their suitability for protein mixtures. Both TSKgel HIC-ADC columns exhibit superior separation performance relative to alternative HIC columns. When comparing the TSKgel HIC-ADC Phenyl and Butyl profiles, the Phenyl column better resolves less hydrophobic proteins including myoglobin, RNAseA, and lysozyme and increases retention for all molecules tested in the mix. On the other hand, the more hydrophobic proteins are eluted with superior peak shapes using the TSKgel HIC-ADC Butyl column. Enable Faster Throughput for DAR analysis with the 3.5 cm TSKgel HIC-ADC column, DAR determinations can be reduced to a 7-minute run time while preserving performance analyzed with its 10 cm equivalent. Now run times can be accelerated without compromising on accuracy or resolution, ensuring faster results without sacrificing quality.
Tosoh Bioscience Japan