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Comprehensive multi-attribute method workflow for biotherapeutic characterization and current good manufacturing

Silvia Millán-Martín1, Craig Jakes1,2, Sara Carillo1

  • 1National Institute for Bioprocessing Research and Training, Dublin, Ireland.

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|December 16, 2022
PubMed
Summary
This summary is machine-generated.

The multi-attribute method (MAM) offers a streamlined LC-MS approach for biopharmaceutical quality control. This method directly analyzes numerous product quality attributes, enhancing characterization and monitoring throughout the product lifecycle.

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Area of Science:

  • Biopharmaceutical Analysis
  • Analytical Chemistry
  • Protein Characterization

Background:

  • Conventional assays for biopharmaceuticals are often less informative and streamlined.
  • There is a need for direct, comprehensive monitoring of product quality attributes (PQAs).

Purpose of the Study:

  • To introduce and detail the multi-attribute method (MAM) as an advanced LC-MS technique.
  • To highlight MAM's capability in directly characterizing numerous PQAs of biopharmaceuticals.

Main Methods:

  • MAM utilizes proteolytic digestion followed by reversed-phase LC-MS analysis.
  • It involves a discovery phase for attribute identification and a monitoring phase using a targeted peptide library.
  • Differential analysis of data aids in detecting changes in product attributes.

Main Results:

  • MAM enables direct identity testing via primary sequence verification.
  • It allows for the detection and quantitation of post-translational modifications and impurities.
  • MAM provides a more informative and productive workflow compared to traditional methods.

Conclusions:

  • MAM is a powerful tool for comprehensive biopharmaceutical characterization and quality control.
  • The method supports product development and manufacturing under GMP regulations.
  • MAM enhances the direct monitoring of critical quality attributes throughout the product lifecycle.