Development of a Robust Multi-Attribute Method Suitable for Implementation in a QC Environment
What is the Multi-Attribute Method?
The multi-attribute method, known as MAM, employs a liquid chromatography-mass spectrometry (LC-MS) technique. It serves as a peptide mapping application, enabling the direct analysis and monitoring of a wide array of product quality attributes (PQAs) at the amino acid level in biopharmaceutical products. This method is applicable throughout the product's journey from process development to quality control release.
Even minor alterations in the protein sequence can significantly impact the safety and biological effectiveness of biotherapeutics. Through direct measurement of potential PQAs, valuable insights are gained to refine production processes, ultimately enhancing the overall product quality.
The meticulous evaluation and continuous tracking of potential PQAs play a pivotal role in ensuring the product's quality, safety, and efficacy. Traditional methods for assessing potential PQAs involve resource-intensive approaches like multiple chromatographic and electrophoretic techniques. However, these methods are profile-based and often fall short in identifying and quantifying potential PQAs linked to specific residues. Incorporating the MAM approach can revolutionize the understanding and optimization of biopharmaceutical production, offering a comprehensive and efficient means to maintain product excellence.
The streamlined workflow to bring safe, high-quality medicines to market faster.
Straight through to breakthrough: Thermo Scientific MAM 2.0 Workflow
The multi-attribute method analytical solutions guide
The MAM 2.0 workflow enables seamless transition from research and development to quality control
Thermo Scientific MAM 2.0 Workflow
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.
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.
On-demand Webinar: Toward a Next-Generation Multi-Attribute Method (MAM): An Evaluation of the Orbitrap Exploris MX Mass Detector
Presented by Andrew W. Dawdy, Ph.D., Principal Scientist, BioTherapeutics Pharmaceutical Sciences Pfizer, Inc.
Key features
A scalable MAM platform 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.
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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Recommended configuration – Attribute Characterization | Request a quote |
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Recommended configuration – Routine Monitoring | Request a quote |
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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
From instrument control and data acquisition to automated data processing to customizable reports to easy electronic data reviews Chromeleon CDS facilitates compliant-ready CQA monitoring and new peak detection while ensuring data integrity requirements are met. User defined roles and permissions with the benefits of a scalable enterprise system provide the environment for global collaboration to ensure seamless method transfer and execution from development to QC.
BioPharma Finder software
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.
Ardia platform
The Thermo Scientific Ardia platform is designed for scientists running chromatography and mass spectrometry analyses and enables them to combine, aggregate, compare, interrogate and share information via a common digital language. It allows for the highest uptime, security, and global compliance standards in the sharing of previously siloed data.
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.
Resources
Quality by Design
See how MAM 2.0 brings “Quality by Design” to Biotherapeutic Development
Orbitrap Exploris MX interactive video
Interact with this unique video to learn more about this system and how it can be the perfect fit for your laboratory.
MAM 2.0 Customer Journey Video
MAM pioneers share their experiences in moving MS into QC, overcoming key challenges, and what the future holds.
Multi-Attribute Method 3D Virtual Lab
Experience an immersive 3D virtual lab with interactive workflow demonstrations and discover the MAM 2.0 solution.
MAM 2.0 references
Application Notes
Brochures
Flyers
White Papers
Videos
Industry insight
MAM Case Study with Rich Rogers – MAM Consortium
Hear Rich Rogers discuss his vision of what the future may hold for the multi-attribute method (MAM) in the biopharmaceutical industry.
Building a Cross-Site Lab-of-the-Future
Learn how Pfizer successfully developed a robust multi-site “Lab of the Future” to implement MAM for biotherapeutic development.
Putting MAM on the Map
Learn the journey of MAM from idea to real-world implementation at Amgen.
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Style Sheet for Global Design System