Attribute Analytics Performance Metrics from the MAM Consortium Interlaboratory Study

Area of Science:

• Biopharmaceutical Analysis
• Analytical Chemistry
• Mass Spectrometry

Background:

• The multi-attribute method (MAM) was developed as a single, comprehensive assay for protein therapeutics.
• MAM utilizes mass spectrometry (MS) for identifying and quantifying numerous protein attributes.
• Current quality control (QC) relies on multiple, established orthogonal methods, hindering MAM adoption in QC labs.

Purpose of the Study:

• To evaluate the current industry-wide status of MAM implementation.
• To assess the targeted attribute analytics component of MAM.
• To identify sources of interlaboratory variability and compare MAM data with orthogonal methods.

Main Methods:

• An interlaboratory study was conducted by the MAM consortium.
• Targeted attribute analytics were investigated within the MAM framework.
• Data from MAM were compared against results from established orthogonal methods.

Main Results:

• Variability between laboratories using MAM was investigated.
• MAM data demonstrated comparability with orthogonal methods for targeted attributes.
• Specific sources contributing to interlaboratory variability were identified.

Conclusions:

• MAM shows potential as a unified assay for protein therapeutic characterization.
• Addressing identified sources of variability is crucial for routine QC implementation.
• Further optimization efforts can facilitate broader adoption of MAM in QC settings.