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Published on: January 19, 2024

Redefining biologics safety through advanced analytics: MS-based host cell protein profiling.

Paresh Tank1, Fatima D'Souza2, Nagarajan Kayalvizhi3

  • 1Amity Institute of Biotechnology, Amity University, Mumbai, Pune Expressway, Bhatan, Post-Somathne, Panvel, Mumbai, Maharashtra 410 206, India; Analytical Chemistry Division of Zelle Biotechnology Research and Analytical Services, Zelle Biotechnology Pvt. Ltd., A-7 M.I.D.C., Mira Industrial Area, Western Express Highway, Mira Road, Thane, Maharashtra 401 104, India.

Trends in Biotechnology
|June 2, 2026
PubMed
Summary

New liquid chromatography-mass spectrometry (LC-MS) methods offer detailed analysis of host cell protein (HCP) impurities in biologics. This advanced profiling enhances impurity risk assessment and supports biologics safety and quality.

Keywords:
biologics qualitybiopharmaceutical analyticshost cell proteinsmass spectrometryprocess-related impuritiesregulatory science

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Area of Science:

  • Biopharmaceutical manufacturing
  • Analytical chemistry
  • Protein biochemistry

Background:

  • Regulatory bodies and pharmacopeias increasingly focus on host cell protein (HCP) impurities in biologic drugs.
  • Traditional immunoassays for HCP detection have limitations in specificity and scope.
  • Advances in analytical techniques are needed for comprehensive HCP characterization.

Purpose of the Study:

  • To explore the application of liquid chromatography-mass spectrometry (LC-MS) for host cell protein (HCP) impurity profiling in biologics.
  • To demonstrate how LC-MS enhances the understanding of HCP impurities beyond current immunoassay capabilities.
  • To evaluate the impact of LC-MS-based HCP profiling on risk assessment and analytical strategies for biologics.

Main Methods:

  • Utilizing advanced liquid chromatography-mass spectrometry (LC-MS) for high-resolution separation and identification of HCPs.
  • Applying LC-MS for molecular-level characterization of HCP impurities present in biologic drug substances.
  • Comparing LC-MS profiling data with traditional immunoassay measurements for HCPs.

Main Results:

  • LC-MS enables detailed, molecular-level identification and quantification of a broader range of HCPs compared to immunoassays.
  • HCP profiling using LC-MS provides enhanced insights into process-related impurities.
  • The data supports the utility of LC-MS in strengthening impurity risk assessments for biologics.

Conclusions:

  • LC-MS-based HCP profiling offers a powerful, complementary approach to traditional methods for biologics.
  • This advanced analytical strategy improves process understanding and strengthens the quality and safety assessment of biologic drugs.
  • Implementing LC-MS profiling supports robust analytical strategies for biopharmaceutical development and manufacturing.