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Using New Peak Detection to Solve Sequence Variants Analysis Challenges in Bioprocess Development.

Ben Niu1, Yali Lu1, Xiaoyu Chen1

  • 1Analytical Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland20878United States.

Journal of the American Society for Mass Spectrometry
|January 27, 2023
PubMed
Summary
This summary is machine-generated.

Detecting low-level protein sequence variants (SVs) in therapeutic proteins is crucial for safety. This study introduces a faster, more reliable LC-MS/MS method for identifying these critical SVs during bioprocess development.

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Area of Science:

  • Biopharmaceutical development
  • Analytical chemistry
  • Protein therapeutics

Background:

  • Recombinant therapeutic proteins are a major drug class.
  • Low levels of protein sequence variants (SVs) can be present.
  • Detecting SVs is vital for controlling immune responses and ensuring drug safety.

Purpose of the Study:

  • To develop a highly sensitive and rapid method for detecting and identifying low-level protein sequence variants (SVs).
  • To improve the analysis of SVs during clone selection and early process development for therapeutic proteins.

Main Methods:

  • Utilized peptide mapping with liquid chromatography-tandem mass spectrometry (LC-MS/MS).
  • Implemented an optimized approach featuring novel peak detection algorithms.
  • Focused on enhancing the speed and confidence of SV identification.

Main Results:

  • Successfully detected and identified low-level sequence variants with high confidence.
  • The optimized method significantly increased the speed of SV analysis.
  • Demonstrated the broad applicability and practicality of the new approach.

Conclusions:

  • The developed LC-MS/MS approach provides a practical and efficient solution for analyzing low-level SVs in therapeutic proteins.
  • This method supports robust bioprocess development and quality control strategies.
  • Enhances the ability to ensure the safety and efficacy of protein-based therapeutics.