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New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study.

Trina Mouchahoir1,2, John E Schiel1,2, Rich Rogers3

  • 1National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, Maryland 20899, United States.

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|March 12, 2021
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Summary

The Multi-Attribute Method (MAM) Consortium evaluated new peak detection (NPD) performance across 28 labs. Results show current NPD methods align with high-resolution mass spectrometry, identifying key variability factors for improved protein therapeutic analysis.

Keywords:
MAM ConsortiumNISTmAbmulti-attribute methodnew peak detectionpurity testing

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Area of Science:

  • Analytical Chemistry
  • Biopharmaceutical Analysis
  • Mass Spectrometry

Background:

  • The Multi-Attribute Method (MAM) is an emerging ultra-high-performance liquid chromatography-mass spectrometry (UHPLC-MS) application for biopharmaceutical characterization.
  • Widespread adoption of MAM as a purity-indicating assay necessitates robust new peak detection (NPD) methodologies for identifying process- and product-related impurities.

Purpose of the Study:

  • To assess the industry-wide performance of NPD methodologies within the biopharmaceutical sector.
  • To identify critical factors influencing NPD variability and performance for the MAM platform.
  • To provide data for refining NPD methods and accelerating MAM adoption in protein therapeutic development.

Main Methods:

  • An interlaboratory study was conducted by the MAM Consortium involving 28 participating laboratories.
  • Predigested samples of NISTmAb Reference Material 8671 were used to evaluate NPD performance.
  • Analysis focused on the parameters utilized for NPD and their correlation with high-resolution MS capabilities.

Main Results:

  • Industry-wide NPD parameters are generally representative of high-resolution MS performance.
  • The study identified specific elements of NPD that contribute to variability in the number of detected new peaks.
  • Performance data from 28 laboratories provide a benchmark for current NPD practices.

Conclusions:

  • The NPD interlaboratory study provides valuable insights into the current state of practice for MAM implementation.
  • Understanding and addressing identified sources of variability in NPD are crucial for enhancing the reliability of MAM purity assessments.
  • The findings will aid in refining NPD methodologies, ultimately accelerating the integration of MAM into protein therapeutic product life cycles.