Multi-Attribute Methods for Biopharmaceutical Analysis

The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over recent years.

The ability to directly assess the molecular attributes that contribute to efficacy, safety, stability, and process robustness is enabling analysts and their organizations to obtain more data without the ambiguity of standardized chromatographic and electrophoretic assays that measure product variation indirectly. In many cases, this data is generated with greater sensitivity and dynamic range than these legacy assays, furthering the discussion whether MAM complements or eventually replaces these traditional analyses in development, manufacturing, and quality organizations.

This web page presents a wealth of resource related to the capabilities and adoption of MAM workflows within the biopharmaceutical industry. These include perspectives from the scientific community, webinars showing application examples, high level expert opinion on MAM implementation and application notes detailing method conditions.

Hear From Experts Across Industry, Academia and Regulatory About Their Expertise in Implementing MAM

Waters Corporation: Expert Discussion Series - Multi-Attribute Methods

• The Opportunities and Challenges of MAM
  • What are the opportunities and challenges of MAM? Hear from the experts. 5 Minute Discussion
  • VIDEO
• Sample Preparation and Automation
  • How to ensure sample preparation robustness and repeatability? 6 Minute Discussion
  • VIDEO
• Considerations of New Peak Detection
  • How to effectively approach new peak detection? Here are some tips and tricks. 6:30 Minute Discussion
  • VIDEO
• How Accessible is MAM to Routine Labs?
  • Learn how feasible MAM is for routine analysts. 7 Minute Discussion
  • VIDEO
• Informatics Requirements for MAM
  • Get expert advice on informatics requirements for MAM. 6 Minute Discussion
  • VIDEO
• System Requirements for MAM
  • What system requirements are needed to implement MAM effectively? 8:30 Minute Discussion
  • VIDEO

Hear from Key Opinion Leaders About Their Experiences Implementing MAM

• Quality Assistance - MAM at Peptide or Subunit Levels: Ready for QC
  • Hear customer perspectives on how to effectively implement MAM in a regulated environment.
  • RECORD
• Pfizer - Streamlining and Accelerating Peptide MAM with a BioAccord
  • Learn how to increase process and product knowledge through both PQA monitoring and new peak detection.
  • RECORD
• Merck - MAM Deployment for QC Analytical Testing
  • Learn the opportunities and challenges related to the adoption of the MAM method across the entire spectrum, ranging from R&D to commercial QC for the release.
  • RECORD

Access Additional Resources Below

• Attribute Monitoring Workflows
  • Connect molecular attributes to product and process knowledge using the BioAccord LC-MS System.
  • Infographic
• MAM for Biopharmaceutical Analysis
  • Learn how to improve and streamline MAM analysis of biotherapeutic proteins.
  • Application Notebook
• MAM for Biopharmaceutical Analysis
  • Hear from MAM experts for their perspectives on the adoption of LC-MS based attribute analysis for biopharmaceuticals.
  • eBook

BioAccord System Demo Series

Waters Corporation: BioAccord System Demo Series

• Demo 1 | Peptide Multi-Attribute Method Overview 
  • Get a quick overview of the Peptide MAM app as part of the waters_connect platform.
  • VIDEO
• Demo 2 | Creating a Processing Method
  • Get a deeper dive in waters_connect to learn how to create a processing method for Peptide MAM.
  • VIDEO
• Demo 3 | Creating an Analysis
  • Create an analysis using the Peptide MAM app as part of waters_connect.
  • VIDEO
• Demo 4 | Reviewing Data and Attributes
  • Learn how to further review data and attributes in waters_connect.
  • VIDEO
• Demo 5 | New Peak Detection and Reporting
  • Look at new peak detection and reporting using the Peptide MAM app in waters_connect.
  • VIDEO

For complete information, please visit the Multi-Attribute Methods for Biopharmaceutical Analysis website