Multi-Attribute Method (MAM): An Emerging Analytical Workflow for Biopharmaceutical Characterization, Batch Release...

Area of Science:

• Biopharmaceutical analysis
• Analytical chemistry
• Mass spectrometry

Background:

• The biotherapeutic industry faces challenges with complex molecules, necessitating advanced analytical platforms.
• Traditional methods struggle with comprehensive quality attribute assessment.
• Mass spectrometry (MS) offers superior sensitivity and detailed information for biotherapeutic quality control.

Purpose of the Study:

• To review the current landscape and applications of the multi-attribute method (MAM) in biopharmaceutical characterization.
• To highlight the advantages of MAM for cGMP testing and quality attribute monitoring.
• To discuss industry acceptance and regulatory considerations for MAM implementation.

Main Methods:

• Liquid chromatography-mass spectrometry (LC-MS) based analytical approach.
• Monitoring multiple quality attributes at both peptide and intact levels.
• Review of current instrumentation, software, and regulatory requirements for MAM.

Main Results:

• MAM enables simultaneous monitoring of multiple quality attributes in a single assay.
• Increased analytical throughput compared to traditional methods.
• Facilitates streamlined biopharmaceutical production from R&D to QC.

Conclusions:

• MAM is an emerging and powerful platform for biotherapeutic characterization and cGMP testing.
• It offers significant advantages in efficiency and data richness.
• Industry acceptance and regulatory alignment are key for widespread MAM adoption.