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 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. ​
Thermo Scientific MAM 2.0

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.

Systems

Thermo Scientific end-to-end MAM solution designed for development through QC

SeparationMass SpectrometryEnterprise Data ManagementSystem Performance Evaluation Tests (SETs)
UHPLCOrbitrap 240 ExplorisEnterprise Data ManagementSet Check List
  • Vanquish Horizon UHPLC System
  • Vanquish Flex UHPLC systems
  • Hypersil GOLD HPLC Columns
  • Orbitrap Exploris 240 Mass Spectrometer
  • Orbitrap Exploris MX Mass Detector
  • Chromeleon CDS 7.3.1*
  • BioPharma Finder Software 5.0*
  • HyperBridge Software*
  • BSA Digest
  • SET Methods
  • Support

     

  • *coming soon

    Recommended configuration - Attribute Characterization

    Hypersil Gold Vanquish Columns   Arrow   UPLCS Instrument    Arrow   CM    Arrow       Arrow      Biopharma Software


    Recommended configuration – Routine Monitoring

    Hypersil Gold Vanquish Columns  Arrow  Arrow OE MX Arrow    CM   

    Thermo Scientific MAM 2.0 solutions in depth

    Future proof your biotherapeutic development and QC with industry proven Orbitrap technology, now purposely designed for MAM.

    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.

    BioPharma Finder 5.0 software

    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

    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) Checklist

    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.

    Standardized System Performance Evaluation Test (SET) Cogs

    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 - Everything You Need to Bring Your Biotherapeutic Straight Through to Breakthrough

    MAM 2.0 flyer

    Everything You Need to Bring Your Biotherapeutic Straight Through to Breakthrough

    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:

    Style Sheet for Komodo Tabs
    Style Sheet for Global Design System
    CMD SchemaApp code