Tracking the Behavior of Monoclonal Antibody Product Quality Attributes Using a Multi-Attribute Method Workflow

Area of Science:

• Biopharmaceutical Analysis
• Analytical Chemistry
• Mass Spectrometry

Background:

• Biotherapeutics require comprehensive quality attribute monitoring.
• Conventional assays can be time-consuming and limited in scope.
• The multi-attribute method (MAM) offers a consolidated LC-MS approach.

Purpose of the Study:

• To evaluate the robustness and accuracy of a high-resolution MAM workflow.
• To demonstrate MAM's suitability for biopharmaceutical characterization and impurity detection.
• To showcase MAM's application in a Current Good Manufacturing Practice (CGMP) environment.

Main Methods:

• Utilized liquid chromatography-mass spectrometry (LC-MS) with high-resolution accurate mass spectral data.
• Applied automated data analysis for characterization and new peak detection.
• Implemented the MAM workflow across three distinct case studies.

Main Results:

• Successfully monitored monoclonal antibody quality attributes during a 12-day cell culture process.
• Assessed product purity and identity in the presence of host cell proteins.
• Compared a drug product and biosimilar, identifying sequence variants.

Conclusions:

• The MAM workflow demonstrates high accuracy and robustness for biotherapeutic analysis.
• MAM effectively characterizes product quality attributes and detects impurities.
• The method is suitable for deployment in regulated biopharmaceutical manufacturing environments.