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Multi-dimensional technology - Recent advances and applications for biotherapeutic characterization.

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Multi-dimensional liquid chromatography-mass spectrometry (mD-LC-MS) is maturing for complex products. Online workflows enhance efficiency and reduce artifacts, paving the way for real-time biopharmaceutical quality monitoring.

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Area of Science:

  • Analytical Chemistry
  • Biochemistry
  • Biotechnology

Background:

  • Multi-dimensional liquid chromatography coupled with mass spectrometry (mD-LC-MS) has evolved significantly.
  • Traditional offline workflows present challenges in sample processing and analysis time.

Purpose of the Study:

  • To review recent advancements and applications of mD-LC-MS.
  • To explore the potential of mD-LC-MS as a process analytical technology (PAT) tool.
  • To identify emerging trends and future directions in the field.

Main Methods:

  • Review of current literature and inter-laboratory studies.
  • Analysis of workflow improvements, including the shift from offline to online mD-LC-MS.
  • Discussion of applications in complex product analysis and biopharmaceutical monitoring.

Main Results:

  • Online mD-LC-MS workflows reduce artifacts, variability, and analysis time.
  • The technique is mature for diverse complex product applications.
  • Potential exists for real-time monitoring of monoclonal antibody quality.

Conclusions:

  • mD-LC-MS is a powerful technique for characterizing complex products.
  • Emerging trends include new modalities, biological activity evaluation, and capillary electrophoresis alternatives.
  • mD-LC-MS is poised to shape next-generation analytical tools for biopharmaceuticals.