HR Multi-Attribute Method

The HR Multi-Attribute Method (HR MAM) is a powerful high resolution accurate mass (HRAM) mass spectrometry (MS)-based workflow, delivering comprehensive characterization and monitoring of biotherapeutic products. Built within a safe compliant environment, the HR MAM allows characterization of biologics with ease and allows product quality attributes to be monitored throughout every stage of the drug development process, while also enabling purity testing and new peak detection. The high quality data generated by the combination of high resolution chromatography and HRAM MS is seamlessly interrogated by a powerful software workstream to provide the maximum confidence in securing product quality.

The HR Multi-Attribute Method (HR MAM) includes all the necessary components for a successful biopharmaceutical quality attribute characterization and quantitation workflow, including the following:

• System suitability test using a Pierce™ BSA Protein Digest standard.
• Industry-leading high resolution Q Exactive™ Plus Hybrid Quadrupole Orbitrap™ mass spectrometer coupled with state-of-the-art Vanquish™ Horizon UHPLC and column.
• Workflow support and training from the global network of Thermo Fisher Scientific MAM experts.

Key benefits of HR MAM:

• Reduce the number of analyses with the implementation of a single method.
• Gain an increased level of information for product quality attribute identification and CQA monitoring, while reducing the number of analyses needed by conventional methods.
• Remove doubts with improved resolution and higher data quality through the application of high resolution mass spectrometry.
• Ensure accurate detection and quantification of all variants and modifications.
• Eliminate false quantitation with the help of composite peptide scoring and separation of isotopes/charge states.

Know more unknowns

Take advantage of another dimension and find out what is missed. Detect sample impurities with HRAM-based new peak detection.

Seamlessly transfer your analytical method into routine monitoring.

Apply generated protein characterization data to quality attribute identification using BioPharma Finder software. Integrate seamlessly into routine and compliant monitoring using the powerful MS processing features of Chromeleon Chromatography Data System (CDS).