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Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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Development of a comprehensive approach for performance evaluation of a quantitative multi-attribute method as a

Eriko Numao1, Kumi Yanagisawa2, Mayu Hosono2

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Analytical Sciences : the International Journal of the Japan Society for Analytical Chemistry
|March 17, 2022
PubMed
Summary

The multi-attribute method accurately quantifies therapeutic protein post-translational modifications (PTMs). Comparing calculation formulas showed minimal differences, validating its reliability for PTM analysis.

Keywords:
Internal standardLC/MSMonoclonal antibodyMulti-attribute method (MAM)Post-translational modification (PTM)

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Area of Science:

  • Biochemistry
  • Analytical Chemistry
  • Pharmaceutical Science

Background:

  • Therapeutic proteins often undergo post-translational modifications (PTMs) that impact their efficacy and safety.
  • Accurate quantification of PTMs is crucial for quality control and characterization of biopharmaceuticals.
  • The multi-attribute method (MAM) offers a site-specific and spontaneous approach for evaluating multiple protein attributes.

Purpose of the Study:

  • To evaluate the reliability of the multi-attribute method (MAM) for quantifying post-translational modifications (PTMs) in therapeutic proteins.
  • To compare PTM abundance calculations using different formula types.
  • To assess the suitability of internal standards (ISs) for method validation and system suitability testing in mass spectrometry (MS).

Main Methods:

  • Comparison of PTM abundance calculations derived from three distinct formula types.
  • Utilized two distinct peptide types as internal standards (ISs) for method evaluation.
  • Employed one IS as a 'standard peak' to establish mass spectrometry (MS) signal strength and performed system suitability tests using IS recovery rates.

Main Results:

  • Calculated PTM abundances showed negligible differences across the three formula types, indicating robustness.
  • Internal standards effectively facilitated method evaluation and system suitability testing.
  • A defined limit of quantification relative to IS ensures consistent MS intensity thresholds across detected peaks.

Conclusions:

  • The multi-attribute method (MAM) provides a reliable and consistent approach for quantifying post-translational modifications (PTMs) in therapeutic proteins.
  • The use of internal standards is effective for validating MAM performance and ensuring mass spectrometry (MS) system suitability.
  • This validated method enables accurate and sensitive detection of minor components and PTMs in biopharmaceutical analysis.