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

 
Key features

A scalable MAM ecosystem built for global connectivity: 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.

Seamless transition from research and development to quality control

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.

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Systems

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

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.

HyperBridge software

HyperBridge software

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 Customer Journey Video

MAM journey as decribed by MAM pioneers. They share their experiences in moving MS into QC, overcoming key challenges and what the future holds.

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