Agilent launches Multi-Attribute Method solution for BioPharma Quality Control

Agilent Technologies Inc. has announced the release of a new multi-attribute method (MAM) workflow designed to help pharmaceutical and biopharmaceutical quality control (QC) laboratories implement liquid chromatography high-resolution mass spectrometry (LC/HRMS) in routine, regulated testing environments.

The Agilent MAM solution brings together software, instrumentation, columns, consumables and standards to address practical and operational barriers that have historically limited the use of LC/HRMS in QC environments. The workflow is designed to support laboratories applying MAM to monitor critical quality attributes during late-stage development and commercial manufacturing.

Regulatory and industry interest in MAM has increased as biologics grow more complex, and expectations for analytical control continue to evolve. Guidance such as United States Pharmacopeia (USP) chapter <1060> highlights considerations for implementing MAM using LC/HRMS, reinforcing its relevance for QC lot release and ongoing manufacturing control.

The solution is designed to integrate into existing QC labs using OpenLab CDS, supporting method transfer from research and development into manufacturing. By streamlining data acquisition, analysis, and reporting, the workflow aims to reduce complexity and training requirements while supporting efficient batch release.

The Agilent MAM solution is available globally and supports pharmaceutical and biopharmaceutical manufacturers seeking to adopt LC/HRMS-based methods in regulated QC environments.