Multi-Attribute Method for OpenLab CDS
MAM for OpenLab CDS gives you just what you need to move MAM workflows from R&D to QC
- High-resolution mass spectrometry (HRMS) and MAM have transformed biopharma drug discovery, yet QC adoption has lagged due to perceived complexity, high cost, and the need for MS expertise. However, MAM is crucial for ensuring product safety, quality, and regulatory confidence.<br><br>A QC-ready, USP <1060>-aligned MAM solution makes adoption possible without the need for expert MS knowledge, pairing intuitive software with streamlined LC/MS on the Infinity III bio LC and 6230C LC/TOF. Built-in capabilities, such as a ready-to-use system performance check and Agilent VacShield, ensure reliable operation and less downtime. <br><br>This is MAM designed for QC: simple to deploy, easy to use, and fully aligned with regulatory expectations, so your lab can move confidently from R&D to routine QC.
- Transfer methods smoothly from R&D to QC or external labs with less complexity and lower cost using the complete, robust, and reliable Agilent MAM solution
- Save time and minimize errors with a guided step-by-step user interface
- Ensure consistent execution of methods across labs with the system performance check
- Minimize false positives and enhance fold-change detection with the novel new peak detection algorithm
- Eliminate manual data reports and get faster insights with built-in data trending and analytics
- Reduce bottlenecks by supporting multiple users with remote data analysis
- Use the Agilent Infinity III bio LC and 6230C LC/TOF as a practical alternative to highest-resolution MS/MS systems, delivering proven robustness and reducing complexity—without compromising performance
- Multi-Attribute Method for OpenLab CDS is an add-on software that requires OpenLab CDS in a client/server deployment with OpenLab ECM XT
Designed for MAM—Speed, Confidence, Clarity
Execute your biopharma workflows with just what you need—Agilent MAM solution
Overview
1290 Infinity III bio LC
6230C LC/TOF
6545XT AdvanceBio LC/Q-TOF
Features
Easily adopt the complete, robust Agilent MAM solution
Smooth method transfer from R&D to QC with reduced complexity and cost.
System performance check—ease of use
The system performance check (SPC) is an essential readiness tool for successful MAM analysis and is designed to support workflows informed by USP <1060>, but creating this from scratch is difficult for labs new to MAM. Our unique, built-in SPC includes a 13-peptide standard and peptide-optimized column to rapidly confirm readiness.
System performance check—targets view
The Agilent 13-peptide LC/MS standard provides a holistic check of LC/MS performance across the entire system—UHPLC, column, and HRMS—with each component in the system required to meet strict performance requirements. Each peptide is designed to flag specific failure modes before testing begins.
System performance check—results set
System readiness confirms that the analytical system—LC, MS, and software—meets predefined criteria. The built-in SPC enables quick, low-effort LC/MS system checks and readiness verification. In the results view, system performance pass or fail data are summarized for fast, easy review.
System suitability testing
System suitability testing (SST) is a fundamental quality control activity for MAM, ensuring that the LC/TOF system is fit for its intended purpose before sample analysis begins. A guided interface with easy readout in the MAM software supports your system suitability testing requirements.
Sample acceptance criteria
Sample acceptance criteria, such as tryptic peptide recovery (%), are crucial for ensuring samples are suitable for analysis. Users can easily determine whether a sample passes or fails, as each peptide is displayed in a table alongside its corresponding extracted ion chromatogram (EIC).
Critical quality attributes (CQAs)
CQAs—including primary sequence—are clearly shown in table format, with out-of-spec values explicitly highlighted. Corresponding extracted ion chromatograms (EICs) and spectra are easily accessible. Users with appropriate permissions can perform manual peak integration directly in the user interface.
Purity assessment with new peak detection
New peak detection (NPD) is a critical step in the MAM data analysis workflow to identify product variants that may affect safety, efficacy, or compliance.
Detect the unexpected with NPD
Using untargeted feature extraction to compare your sample to a reference standard, our novel NPD algorithm minimizes false positives and enhances fold-change detection—delivering accurate results aligned with USP <1060> and regulatory expectations.
Results flagging in new peak detection workflow
During the critical NPD step in MAM data analysis workflows, a sample is compared against a reference to flag any unexpected peaks—whether new, increased, decreased, or missing. MAM for OpenLab CDS facilitates NPD by clearly indicating if any unexpected peaks are found in a sample.
Reporting
The MAM results report clearly indicates whether an assay meets predefined method criteria. Supporting data, including EICs and chromatographic results, are organized for efficient review.
Data trending
Data trending can be a painstaking process with multiple steps involved, including exporting from the data system, additional parsing of data with scripts to match database schemas, and relying on third-party data visualization tools. With the Agilent MAM solution, data-trending is built-in for easy insights.
Built-in data trending
MAM for OpenLab CDS has built-in data trending and analytics capabilities that give you faster insights and eliminate manual data reports. Batch-to-batch or analyst-to-analyst, trending historical MAM data has never been this easy.
How it works
MAM that moves you forward
Combining software, instruments, columns, and standards, the Agilent MAM solution delivers seamless performance, reliable results, and faster batch release:
- Get proven robustness and reliability with Agilent LC/MS systems
- Rapidly confirm system readiness with our system performance check
- Use the step-by-step user interface (UI) to simplify system suitability testing
- Easily determine pass/fail results in the sample acceptance UI
- Detect the unexpected with new peak detection
- Efficiently trend data by instrument, analysis, or batch
- Eliminate manual reporting
CSV imports to MAM for OpenLab CDS
Even with non-Agilent hardware, you can build out your method with CSV imports to MAM software.
Secure, centralized data—OpenLab CDS
Agilent OpenLab CDS secures data across acquisition, processing, reporting, and storage—supporting the data integrity required for MAM workflows. In a client/server environment, all methods and results are centrally managed, so analysts work from the same consistent, trusted data. Teams can set up methods, monitor instruments, and review results remotely without compromising data control or traceability, helping labs to align with requirements such as 21 CFR Part 11.
Customer stories
“The software is designed in such a way that it's clear what the data mean and what to do next. This is, in my experience to date, the best software that exists for a MAM solution.”
“The new peak detections are a really important part of the method, not only for monitoring potential impurities, but also for monitoring potential changes to the actual molecule itself.”
Jared R. Auclair, PhD
Dean, Northeastern University College of Professional Studies
Director, Bioinnovation
Applications
The Agilent MAM solution combines software, instruments, columns, standards, and services.
The Agilent MAM solution
Transfer methods smoothly from R&D to QC with less complexity and cost using the complete, robust, and reliable Agilent MAM solution. The guided, step-by-step user interface in MAM for OpenLab CDS saves time and minimizes errors. Consistent execution of methods across labs is simplified with the system performance check and related consumables. The Agilent Infinity III bio LC and 6230C LC/TOF are practical alternatives to highest-resolution MS/MS systems, delivering proven robustness and reducing complexity—without compromising performance.
QC-ready software for confident data
Complex software can lead to human error and inaccurate quantitation, making method transfer difficult and compromising compliance. MAM for OpenLab CDS bridges R&D and QC with a guided, step-by-step interface and a single data acquisition system for continuity across environments. Build your method with CSV imports to MAM, even with non-Agilent HRMS results. Simplified workflows support regulatory compliance and rapid, consistent, accurate CQA analysis—without added complexity or training cost.
The right LC and MS for MAM peptide mapping
When implementing MAM, labs may overestimate the need for the highest-resolution mass spectrometry systems, leading to higher costs, reduced robustness, and increased downtime. In contrast, the Agilent 6230C TOF LC/MS system is robust and easy to use, making it an ideal fit for regulated QC environments. The Agilent InfinityLab bio LC portfolio is optimized for peptide mapping and CQA monitoring in MAM workflows. Benefit from enhanced analytical capabilities for biomolecule analysis—without compromising mass accuracy.
Ready-to-use system performance check
The system performance check (SPC) is your essential readiness tool for successful MAM analysis and is designed to support workflows informed by USP <1060>, but creating this from scratch is difficult for labs new to MAM. With our unique, built-in SPC, you can rapidly confirm readiness and streamline checks, supporting method consistency and reducing manual effort. SPC includes Agilent peptide-optimized reversed-phase LC columns designed for high-resolution separation (such as Agilent Altura Eclipse Plus C18 columns) and an SPC standard (Agilent 13-peptide LC/MS standard).
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Specifications
Documents & support
Frequently asked questions
What is MAM analysis, and how is it applied in QA/QC labs?
MAM is a sophisticated analytical technique used to simultaneously monitor multiple site-specific critical quality attributes (CQAs) of biopharmaceutical products, as well as significant product changes. It leverages high-resolution mass spectrometry (HRMS) to ensure product consistency and supports compliance with regulatory standards.
What are the key advantages of MAM over traditional methods in QA/QC?
MAM offers several benefits, including higher specificity, the ability to detect multiple site-specific attributes in a single run, and enhanced sensitivity for identifying product variants and impurities.
Is MAM just LC/MS peptide mapping of a protein?
MAM is much more than traditional LC/MS peptide mapping. It is a regulatory, quantitative method set. MAM involves a system readiness test, the targeted quantitation of multiple CQAs simultaneously—such as measuring a set of peptides in a digest—and new peak detection. This enables identification of unexpected changes in the sample. MAM delivers all this work in a regulatory-compliant manner.
If my manufacturing process is in control, do I need MAM?
A MAM assay is designed to monitor critical attributes that can affect the safety, identity, strength, purity, and quality of a biopharma therapeutic. The intent is to reduce the number of regulated assays needed in the QC space for drug product verification and to provide better measurements of drug product characteristics.
What challenges might QA/QC labs face when implementing MAM?
Common challenges of implementing MAM include the need for specialized equipment and expertise, data management complexities, understanding QA requirements, and method validation. These obstacles can be addressed through proper training, investment in appropriate advanced technologies, and robust data management systems.
What makes the Agilent MAM solution uniquely suited to biopharma QC?
The Agilent MAM solution is designed with the QC environment in mind. The complete offering brings together all components required to successfully follow USP <1060> guidelines. With a robust LC/TOF platform, a peptide standard and column optimized for MAM analysis, and Agilent OpenLab CDS software, analysts can be productive from day one. Together, the Agilent MAM solution enables fast result generation with high confidence while ensuring secure data handling across the QC laboratory.
How does the Agilent MAM solution differ from other MAM solutions?
The Agilent MAM solution simplifies adoption in the QC environment by guiding users through a complete, step-by-step workflow. The intuitive software supports method setup, data acquisition, processing, and reporting, reducing the need for advanced MS expertise and minimizing user to user variability. This guided approach shortens the learning curve and enables consistent, efficient MAM implementation while supporting data integrity in routine QC operations.
Is the Agilent MAM solution ready to support compliant environments?
This solution relies on OpenLab CDS, a software designed for QC labs that must meet 21 CFR Part 11 regulations. The technical controls for data integrity are built in, not an afterthought. On the market for more than 10 years, OpenLab CDS is a proven solution.
Learn more about OpenLab Software data integrity and data management
Can the Agilent MAM solution use other vendors’ systems or consumables?
For best results, the complete Agilent MAM solution is recommended. However, knowing that laboratories may already have evaluated another vendor’s columns, standards, or LCs, this solution is flexible. It can be used as a complete Agilent solution or can incorporate other vendor components for development and transfer from R&D to QC. Although it is not interoperable with other vendors’ HRMS raw data, results acquired from other vendor LC/HRMS systems can be used to develop Agilent MAM methods.
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