Achieve deeper characterization insights to secure your biopharmaceutical development
The Thermo Scientific HR Multi-Attribute Method (MAM) is a powerful high resolution accurate mass (HRAM)-based workflow that enables comprehensive characterization and monitoring of quality attributes from research to quality control (QC). The HR MAM consists of industry-leading hardware and compliance-ready software as well as a system suitability test specifically developed for the workflow. Built within a safe, compliant environment, the HR MAM enables characterization of biologics with ease and allows potential critical quality attributes (CQAs) to be monitored throughout every stage of the drug development process, while also providing purity testing with the feature of new peak detection (NPD).
The ultimate goal of biopharmaceutical development and manufacturing is to deliver the highest quality product, at the lowest cost, and in the shortest timeframe possible. Biopharmaceutical scientists can now take advantage of a single-vendor, HRAM-based analytical workflow that may replace many of the time-consuming methods typically required for the characterization and QC of therapeutic proteins. Traditional methods are profile-based and are often not capable of identifying and quantifying potential amino acid residue-specific CQAs. The HR MAM enables identification, quantitation, and monitoring of multiple CQAs simultaneously as well as NPD in a verified workflow, serviced and supported by MAM experts from a single vendor. Other HR MAM benefits include:
- Potential reduction in cost and time, as well as fewer SOPs and instruments to maintain.
- A standardized workflow solution for your analytical processes on multiple instruments across different development sites, from research and development to manufacturing and QC.
- Global environment - workflow standardization offers peace of mind when preparing regulatory filings.
- Full workflow support, globally, from a dedicated team of Thermo Fisher Scientific MAM experts.
The HR MAM workflow employs all the necessary components for a successful peptide mapping-based biopharmaceutical characterization workflow. The workflow includes:
- System suitability test standard and high quality solvents.
- Industry-leading, high-resolution Thermo Scientific Q Exactive Plus Mass Spectrometer coupled to a state-of-the-art Thermo Scientific Vanquish™ Horizon UHPLC system and Thermo Scientific Accucore™ Vanquish™ C18+ column.
- BioPharma Finder™ Software and compliance-ready Thermo Scientific Dionex™ Chromeleon™ Chromatography Data System (CDS) for data acquisition, attribute characterization, and NPD.
- MAM-specific training.
- Full support from the Thermo Fisher Scientific global expert network.
The HR MAM workflow contains a system suitability test standard, LC and MS hardware, and data acquisition and processing software.
Fully verified protocol with dedicated standards and reagent kits
The Pierce BSA Protein Digest Standard is used to verify the suitability of the LC/MS system for the HR MAM with defined acceptance criteria in Chromeleon CDS. Fisher Scientific LC-MS grade solvents are used for UHPLC separation.
Confident peptide separations, every time
The Thermo Scientific Vanquish Horizon offers exceptional robustness, high gradient precision, low dispersion, improved reproducibility, and peak efficiency for the high resolution separation needed during targeted peptide quantitation, which is utilized by the HR MAM workflow.
The Thermo Scientific Accucore Vanquish C18+ UHPLC Columns, coupled with the Vanquish UHPLC system, take advantage of the extended pressure capabilities of the system and utilize it to its full potential. The UHPLC columns, which contain 1.5 µm solid core particles, deliver exceptionally sharp peaks, maximal peak capacities, and remarkably low retention time variations. This enables reproducible peptide mapping for reliable batch-to-batch analysis during routine QC applications.
Confidence from Discovery to Routine - High Resolution always on!
The Thermo Scientific Q Exactive Plus Mass Spectrometer provides the high resolution and accurate mass detection necessary for specificity to obtain full sequence information and in-depth characterization of biotherapeutic proteins.
Other benefits include:
- Sensitive, accurate, and confident peptide mapping of therapeutic proteins with unparalleled acquisition speed, mass accuracy, and spectral quality.
- Exceptional confidence in identification of peptides and modifications for targeted quantitation and faster batch interrogation.
- Identification of component peptides to within ± 3 ppm for accurate extraction of peaks for routine monitoring and quantitation.
- Linearity across 5 orders of magnitude, which is ideal for complex and varied peptide mixtures, and detection of very low abundance modifications in need of quantitation by the HR MAM workflow.
Seamless Transition from Discovery to Routine – Securing Biopharmaceutical Quality Control
The Thermo Scientific BioPharma Finder software is ideally suited to the discovery step of the Multi-Attribute method, providing high confidence peptide identification and rapid sequence mapping.
Seamless connectivity to the Thermo Scientific Chromeleon Chromatography Data System software ensures compliant workflows.
The Thermo Scientific Chromeleon Chromatography Data System delivers superior compliance tools, networking capabilities, instrument and data acquisition control, automation, compliant-ready data processing and easy reporting, making the Chromeleon CDS an ideal platform for routine monitoring of potential CQAs at any phase of drug development.
Achieve analysis compliance in an enterprise environment—from method creation to final reporting.
Global, dedicated expert support network
The HR Multi-Attribute Method is an end-to-end analytical workflow with the following advantages:
- A Thermo Fisher Scientific product portfolio, combined with service excellence.
- System verification at installation.
- Specialized customer training.
- Expert technical and application support from a dedicated global HR MAM workflow specialist network that safeguards your journey to confidence.
Fully verified protocol with dedicated standards and reagent kits
The Pierce BSA Protein Digest Standard is used to verify the suitability of the LC/MS system for the HR MAM with defined acceptance criteria in Chromeleon CDS. Fisher Scientific LC-MS grade solvents are used for UHPLC separation.
Confident peptide separations, every time
The Thermo Scientific Vanquish Horizon offers exceptional robustness, high gradient precision, low dispersion, improved reproducibility, and peak efficiency for the high resolution separation needed during targeted peptide quantitation, which is utilized by the HR MAM workflow.
The Thermo Scientific Accucore Vanquish C18+ UHPLC Columns, coupled with the Vanquish UHPLC system, take advantage of the extended pressure capabilities of the system and utilize it to its full potential. The UHPLC columns, which contain 1.5 µm solid core particles, deliver exceptionally sharp peaks, maximal peak capacities, and remarkably low retention time variations. This enables reproducible peptide mapping for reliable batch-to-batch analysis during routine QC applications.
Confidence from Discovery to Routine - High Resolution always on!
The Thermo Scientific Q Exactive Plus Mass Spectrometer provides the high resolution and accurate mass detection necessary for specificity to obtain full sequence information and in-depth characterization of biotherapeutic proteins.
Other benefits include:
- Sensitive, accurate, and confident peptide mapping of therapeutic proteins with unparalleled acquisition speed, mass accuracy, and spectral quality.
- Exceptional confidence in identification of peptides and modifications for targeted quantitation and faster batch interrogation.
- Identification of component peptides to within ± 3 ppm for accurate extraction of peaks for routine monitoring and quantitation.
- Linearity across 5 orders of magnitude, which is ideal for complex and varied peptide mixtures, and detection of very low abundance modifications in need of quantitation by the HR MAM workflow.
Seamless Transition from Discovery to Routine – Securing Biopharmaceutical Quality Control
The Thermo Scientific BioPharma Finder software is ideally suited to the discovery step of the Multi-Attribute method, providing high confidence peptide identification and rapid sequence mapping.
Seamless connectivity to the Thermo Scientific Chromeleon Chromatography Data System software ensures compliant workflows.
The Thermo Scientific Chromeleon Chromatography Data System delivers superior compliance tools, networking capabilities, instrument and data acquisition control, automation, compliant-ready data processing and easy reporting, making the Chromeleon CDS an ideal platform for routine monitoring of potential CQAs at any phase of drug development.
Achieve analysis compliance in an enterprise environment—from method creation to final reporting.
Global, dedicated expert support network
The HR Multi-Attribute Method is an end-to-end analytical workflow with the following advantages:
- A Thermo Fisher Scientific product portfolio, combined with service excellence.
- System verification at installation.
- Specialized customer training.
- Expert technical and application support from a dedicated global HR MAM workflow specialist network that safeguards your journey to confidence.
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