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

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.