The biopharmaceutical industry continues to develop protein-based biotherapeutics in increasing numbers. Due to their complexity and biotechnological production, there are many attributes that need to be analyzed to guarantee their safety and efficacy. Peptide mapping is used to measure several critical quality attributes (CQA) required for the characterization of any biotherapeutic protein. The analysis is used to confirm that the correct sequence has been expressed for the protein and to check for post-translational and chemical modifications.

The Thermo Scientific Vanquish UHPLC system with Fluorescence detection is applied for the rapid glyco-profiling of a commercial chimeric IgG1 mAb.The separation is performed on a Thermo Scientific Accucore-150-Amide HILIC column in under 2.5 minutes. The developed methodology offers an excellent analytical platform for ultrafast glycan profile comparison of different batches​ of these mAbs.

The Thermo Scientific Vanquish H system with fluorescence detection is applied for the rapid glycoprofiling of a commercial chimeric IgG1 mAb. The separation is performed on a Thermo Scientific Accucore-150-Amide HILIC column in under 2.5 minutes. Developed methodology offers an excellent analytical platform for ultrafast glycan profile comparison of various production batches.

Analysis of protein aggregation of five important biotherapeutic monoclonal antibodies (mAbs) by size-exclusion chromatography, showing the universal applicability of the Thermo Scientific MAbPac SEC-1 column for aggregate analysis of mAbs. The biopharmaceutical industry continues to develop mAb-based biotherapeutics have several key quality attributes that require quantification. This shows the ability to determine quickly and accurately the percentage of aggregates and fragments for five therapeutics as shown with full details in the AN21601 download.

The Thermo Scientific Dionex UltiMate 3000 LC Bio-LC system is applied for the Hydrophobic Interaction (HIC) analysis of Rituximab. The separation was performed on a Thermo Scientific MabPac HIC-20 column at UV detection of 214 nm. With a total run time of 38 minutes the method allows separation of all oxidized and deamidated impurities of Rituximab.