LabSolutions Insight Biologics

Significance of the Topic

Oligonucleotide therapeutics and diagnostics require precise sequence verification and impurity profiling to ensure efficacy and safety in pharmaceutical development and quality control.

Study Objectives and Overview

The application note presents LabSolutions Insight Biologics software as a dedicated workspace for comprehensive oligonucleotide characterization using quadrupole time-of-flight mass spectrometry. It details the workflow from data acquisition to impurity identification and reporting.

Methodology and Instrumentation

LabSolutions Insight Biologics integrates with Shimadzu LCMS-9030 and LCMS-9050 Q-TOF systems for data-dependent acquisition of MS and MS/MS spectra.
Sequence editors allow configuration of nucleotide sequences, linkers, ribose and base modifications, and target impurity lists.
Automated processing identifies chain length variants, nucleotide gaps, modifications, adducts and other impurities using combined MS and MS/MS data.

Used Instrumentation

• Nexera XS inert liquid chromatograph
• LCMS-9030 quadrupole time-of-flight mass spectrometer
• LCMS-9050 quadrupole time-of-flight mass spectrometer

Main Results and Discussion

Real-time display of structural formulas facilitates rapid sequence verification.
Fragment coverage visualization from MS/MS data enhances confidence in sequence assignments and modification site localization.
Simultaneous display of UV and MS component chromatograms streamlines impurity peak validation.
Flexible impurity ratio calculation methods accommodate various quantitative objectives.

Benefits and Practical Applications

Provides a streamlined workflow for oligonucleotide quality control in R&D and regulated environments.
Visual coverage maps and audit trail support ensure regulatory compliance and data integrity.
Batch processing integration with LabSolutions LCMS accelerates high-throughput analysis.

Future Trends and Potential Applications

Integration with automated synthesis and purification platforms for end-to-end sequence confirmation.
Extension to longer oligonucleotides and emerging chemical modifications.
Application of machine learning algorithms to automate spectral interpretation and impurity identification.

Conclusion

LabSolutions Insight Biologics delivers a unified, user-friendly environment for accurate oligonucleotide characterization. Its comprehensive processing, visualization and reporting features make it an essential tool for analytical chemists in pharmaceutical research and quality control.

Reference

• Shimadzu Corporation LabSolutions Insight Biologics Application Note C146-E475 2023