End-to-end MAM solution to move biopharma forward
MAM has been broadly embraced by the biotherapeutic industry and regulatory leaders in recent years. Major biopharmaceutical companies are making significant investments to establish a MAM workflow to future proof the development and manufacturing of their biotherapeutics.
Historically, the implementation of MAM has not been easy or fast due to the absence of a complete commercial MAM solution. Scientists have had to piece together multiple hardware and software components originally designed for different purposes. Such MAM solutions often require expert MS users and are not without challenges when deployed in process development and QC environments.
Being the leading biotherapeutic solution provider and a trusted partner, Thermo Fisher Scientific has been working closely with industry leaders to develop a seamless, fit-for-purpose MAM solution. Significant improvement has been achieved with the introduction of Thermo Scientific MAM 2.0 since the initial HR MAM launch in 2019.
The streamlined workflow to bring safe, high-quality medicines to market faster.
Thermo Scientific MAM 2.0
Thermo Scientific MAM 2.0 enables:
- Fast decision making based on high confidence information of multiple product quality attributes (PQAs) from development through QC, ensured by industry proven Orbitrap technology and Thermo Scientific ChromeleonChromatography Data System (CDS) as GMP supporting data acquisition and processing software.
- Seamless knowledge sharing and method transfer across instruments, functions, departments, and sites throughout the whole organization to accelerate development, enabled by a compliance-ready enterprise data system.
- Maximum productivity through a dedicated global support team of Thermo Fisher MAM experts, providing application specific training and service.
Key features
Enterprise connectivity for enhanced knowledge sharing
Build your process knowledge within a compliance-ready, enterprise MAM data system that connects instruments, functions, departments and sites throughout development and manufacturing, enabling seamless data and knowledge sharing.
Future proof your biotherapeutic development and QC with industry proven Orbitrap technology, now purposely designed for MAM
Simplify your routine operations without compromising data quality on Thermo Scientific Orbitrap Exploris MX mass detector, built on the same platform as Thermo Scientific Orbitrap Exploris 240 mass spectrometer. Eliminate lengthy method development in QC with direct method transfer within compliance-ready Chromeleon CDS software.
Systems
Thermo Scientific end-to-end MAM solution designed for development through QC
| Separation | Mass Spectrometry | Enterprise Data Management | System Performance Evaluation Tests (SETs) |
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*coming soon
Recommended configuration - Attribute Characterization
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Recommended configuration – Routine Monitoring
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Thermo Scientific MAM 2.0 solutions in depth
Hypersil Gold Vanquish C18 UHPLC Columns
These endcapped, ultrapure, silica-based columns deliver significant reduction in peak tailing, providing excellent resolution, efficiency, and sensitivity.
Vanquish Flex and Vanquish Horizon UHPLC Systems
Full biocompatibility systems with industry-leading flow and gradient precision ensure unsurpassed retention time, reproducibility, and peak area precision for high resolution separation and accurate quantification of PQAs.
Future proof your biotherapeutic development and QC with industry proven Orbitrap technology, now purposely designed for MAM.
Orbitrap Exploris 240 Mass Spectrometer
Ensures high confident product quality attributes (PQAs) characterization and quantification with high quality spectra.
- Resolution: up to 240,000 (at m/z 200)
- Mass accuracy: ±1ppm for >5 days with EASY-IC
- Acquisition speed: up to 22Hz
Orbitrap Exploris MX Mass Detector
Designed for QC environment with consistent and reliable unit-to-unit performance and extended life cycle, while delivering the same high quality HRAM data:
- Resolution: up to 180,000 (at m/z 200)
- Mass accuracy: ±3 ppm for a month with a single click calibration
- Acquisition speed: up to 22Hz
Build your process knowledge within a compliance-ready enterprise data system that connects instruments, functions, departments, and sites throughout development and manufacturing, enabling seamless data and knowledge sharing at global scale.
Chromeleon Enterprise Chromatography Data System 7.3.1
(coming soon) Manages all analytical processes from instrument control to data storage and processing, right through to generating the final results on CQAs and new peak detection in both development and QC environments. Chromeleon CDS provides ease of administration, ensures 24/7/365 uptime, and meets modern data integrity and regulatory requirements.
BioPharma Finder 5.0 software
(coming soon) provides confident identification and quantitation of PQAs with easy-to-understand data visualization and customizable reporting tools, introduces the collaboration of data processing and reporting at global scale, ensures data integrity and security in a multi-user collaborative environment, and facilitates defining processing criteria in targeted monitoring.
HyperBridge software
(coming soon) Provides centralized and secure data storage for enhanced collaboration and knowledge sharing.
Maximize productivity and confidence with dedicated MAM Support Team
Standardized System Performance Evaluation Test (SET)
Designed for each system configuration. Supports thorough assessment of the performance of the entire system, based on an SOP containing a defined list of acceptance criteria, at installation and subsequent maintenance appointments, ensuring consistent high-quality results, utilizing Pierce BSA Protein Digest Standard and Fisher Scientific LC-MS grade solvents are used for SETs.
Combination of on-site and remote trainings are conducted by MAM application experts, customizable to meet your needs.
Installation, training, service, and support are managed by a dedicated global support team of Thermo Scientific MAM experts, providing fast response to maximize system uptime and your productivity.
Learn more about MAM 2.0
Quality by Design
See how MAM 2.0 brings “Quality by Design” to Biotherapeutic Development
MAM 2.0 End-to-end Solution
Product Capabilities from Development to Quality Control
MAM 2.0 flyer
Everything You Need to Bring Your Biotherapeutic Straight Through to Breakthrough
An Integrated LC-MS System Performance
Evaluation Test for Peptide Mapping and Monitoring
Thermo Scientific HR MAM
The HR Multi-Attribute Method (HR MAM) is the first complete commercial MAM solution that delivers comprehensive characterization and monitoring of biotherapeutic products. 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+ HPLC column.
- Thermo Scientific BioPharma Finder Mass Informatics Platform for Biopharmaceutical Characterization and compliance ready Chromeleon CDS Software for data acquisition, attribute characterization, and new peak detection (NPD).
