Biopharmaceutical Chromatography Solutions

Importance of the Topic

Characterization of therapeutic biomolecules requires high recovery and resolution across diverse analytes including proteins, peptides, oligonucleotides and glycans.
Such analyses underpin quality control, regulatory compliance and product development in biopharma.

Study Objectives and Overview

This document introduces Phenomenex Biozen chromatography solutions, a unified portfolio combining novel stationary-phase chemistries, bioinert titanium hardware and advanced particle platforms.
The aim is to support critical biopharmaceutical workflows such as peptide mapping, aggregate analysis, charge-variant profiling, glycan and oligonucleotide separations, intact/subunit and intact-mass characterization, and drug-to-antibody ratio determination.

Methodology

Biozen solutions integrate:

• BioTi™ titanium-infused column hardware to minimize priming and non-specific interactions
• Four particle technologies: thermally modified fully porous, core–shell, monosized polymeric non-porous and pore-controlled silica
• Ten tailored chemistries for RP, SEC, HILIC and IEX modalities
• Complementary sample preparation: SPE sorbents, magnetic beads and high-recovery vials

Used Instrumentation

• Shimadzu LC-20A Prominence UHPLC
• Waters ACQUITY H-Class LC/UHPLC
• SCIEX TripleTOF® 6600 and X500B QTOF mass spectrometers
• SCIEX QTRAP® 5500 triple quadrupole

Main Findings and Discussion

• BioTi hardware delivers superior analyte recovery and reproducibility versus stainless steel across peptides, proteins and oligonucleotides
• Peptide XB-C18 and PS-C18 phases achieve full sequence coverage and clear PTM separation
• dSEC-7 (700 Å) and dSEC-2 (200 Å) columns resolve aggregates in AAV serotypes and monoclonal antibodies with low sample consumption
• WCX media separates acidic and basic protein variants under both pH and salt gradients
• Oligo core-shell phases maintain high efficiency at extreme pH for siRNA and antisense analysis
• Biozen Glycan HILIC core-shell phase resolves sialylated N-glycans with narrow peaks in UHPLC runs
• WidePore C4 and Intact XB-C8 phases produce sharp peaks and accurate deconvoluted masses for intact/subunit and intact-mass profiling
• Intact XB-C8 resolves drug-to-antibody ratio distributions in ADC analysis

Benefits and Practical Applications

• High analyte recovery with minimal column conditioning
• Robust and reproducible separations for QA/QC and regulatory filings
• Reduced sample needs enabling low-concentration analyses
• Modular sample preparation kits streamline workflows
• Compatibility with LC, UHPLC and LC-MS platforms

Future Trends and Potential Applications

Ongoing innovation in particle engineering and bioinert hardware will support deeper characterization of novel modalities such as cell and gene therapies.
Automation, native-MS integration and AI-driven method development promise to accelerate biopharma analysis workflows further.

Conclusion

Phenomenex Biozen offers a comprehensive, biocompatible chromatography platform tailored to the evolving needs of biopharmaceutical research and quality control.
By combining advanced chemistries, particle technologies and hardware, Biozen ensures high recovery, superior resolution and robust performance across diverse bioanalytical applications.

References

• Phenomenex internal application notes and brochures
• U.S. Patent Nos. 7,563,367; 8,658,038 (Biozen Oligo)