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A Multi-Laboratory, Multi-Platform Analysis of the Multi-Attribute Method.

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  • 1Office of Pharmaceutical Quality Research, Center for Drug Evaluation and Research, US Food and Drug Administration, Saint Louis, MO 63110, USA.

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Summary
This summary is machine-generated.

The multi-attribute method (MAM) shows promise for replacing traditional quality control (QC) methods in biopharmaceutical analysis. Validation across labs and instruments confirms its capability for quantifying therapeutic protein attributes.

Keywords:
mass spectrometrymonoclonal antibodiesmulti-attribute methodquality control

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Area of Science:

  • Biopharmaceutical Analysis
  • Analytical Chemistry
  • Protein Characterization

Background:

  • The multi-attribute method (MAM) is increasingly used for characterizing therapeutic proteins.
  • Transitioning MAM to quality control (QC) requires method capability assessment and risk analysis.

Purpose of the Study:

  • To assess the capability of a validated MAM for quantifying product quality attributes (PQAs).
  • To compare MAM performance against conventional chromatographic methods (HILIC-FLD, CEX-UV).
  • To evaluate inter-instrument and inter-laboratory variability for MAM transferability.

Main Methods:

  • A validated MAM approach was employed.
  • Quantification of PQAs including glycosylation, deamidation, oxidation, and N-/C-termini.
  • Comparison with hydrophilic interaction chromatography-fluorescence detection (HILIC-FLD) and cation exchange chromatography-ultraviolet (CEX-UV).

Main Results:

  • MAM successfully quantified PQAs under various stability conditions (stressed, long-term, accelerated).
  • Inter-instrument and inter-laboratory data demonstrated MAM's consistency.
  • Correlation between MAM and conventional methods was established.

Conclusions:

  • The study provides essential data for transferring MAM to QC environments.
  • MAM shows potential to replace orthogonal QC methods, enhancing efficiency.
  • Method transferability and correlation are key for QC adoption.