New breakthroughs increase the efficiency of Critical Quality Attribute (CQA) testing and allow for a Multi- Attribute Method (MAM)

Published: 22-Sep-2021

Download new breakthroughs increase the efficiency of Critical Quality Attribute (CQA) testing and allow for a Multi- Attribute Method (MAM) compendium

Production of therapeutic monoclonal antibodies (mAbs) relies on living cells or organisms. Characterisation of the structure of the mAb is extremely complicated due to the diversity of modifications that can occur during the production, storage and formulation process. It can be challenging to establish well-characterised antibody therapeutics and meet current regulatory expectations.

Download Agilent’s Biopharma CQA Efficiencies Compendium and explore the possibility of using multidimensional technologies such as: 2D-LC, high-resolution Mass Spectrometry (MS), novel chemistries and columns to enhance the efficiency in Critical Quality Attributes (CQAs) analysis, the possibility of measuring multiple attributes simultaneously to decrease overall analysis time and how to obtain faster turn-around results.

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  • Online two-dimensional liquid chromatography is an emerging technology. The Agilent InfinityLab 2D-LC system is ideal to solve complex separations and makes it possible to separate co-eluting compounds and achieve the highest peak capacity. Increased resolution can be achieved with heart-cutting and high-resolution sampling or comprehensive 2D-LC for complex mixtures. 2D-LC can also be used for making buffer separations compatible with MS detection and thus eliminates tedious manual sampling handling steps.
  • The Agilent 6545XT AdvanceBio LC/Q-TOF system is designed to handle multiple workflows in biopharmaceutical characterisation. The 6545XT Q-TOF offers higher resolution, increased sensitivity and a larger dynamic range. The hardware and software are geared towards the analysis of intact proteins, large protein fragments (e.g., mAb fragments), peptides and glycans. The added capabilities of the 6545XT Q-TOF, like iterative data acquisition allow greater access to the most information at the intact protein level, enabling you to automatically confirm a sequence through peptide mapping, and confidently understand PTMs.
  • Agilent MassHunter BioConfirm software is part of the comprehensive solution for characterising biopharmaceutical products. The software performs data analysis and reporting. In addition, tools like the drug-to-antibody ratio (DAR) calculator, flexible report templates, and integrated operation with MassHunter WalkUp bring expert LC/MS capabilities to non-experts. Glycosylation plays an important role in many biological processes. It also affects the therapeutics’ efficacy, stability, pharma-kinetics and immunogenicity. Glycan characterisation can be done with several techniques, including HPLC with fluorescence or MS detection. Since glycans are very diverse in composition/structures and are poorly ionised by electrospray, the MS based approach for glycan characterisation has been challenging.
  • InstantPC dye is a novel instant glycan labelling reagent that provides markedly increased MS and fluorescent sensitivity. The traditional glycan analysis is starting with enzymatic glycan release by N-Glycanase (PNGase F) digestion. Followed by sample cleanup and labelling with InstantPC which forms a stable urea linkage with glycosylamines released by rapid N-Glycanase (PNGase F) digestion. This GlykoPrep N-glycan sample preparation kit uses a rapid digestion, instant labelling and cleanup of excess InstantPC label. The Agilent GlykoPrep N-glycan sample preparation kit offers rapid digestion, instant labelling and cleanup.

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