Solutions for Vaccine Testing

Significance of the Topic

Vaccines are complex biological products whose quality, safety and efficacy depend on rigorous process control and analytical verification.
Advanced analytical chemistry techniques are essential to ensure data integrity, monitor critical process parameters, and detect contaminants or residues.

Objectives and Overview

This document presents a suite of modern analytical methods applied to various stages of vaccine development and production.
The goal is to illustrate how combining database management, mass spectrometry, optical emission and light‐scattering techniques can optimize:

• Data integrity management and regulatory compliance
• Cell culture supernatant profiling
• Saccharide unit quantitation in polysaccharide vaccines
• Viral protein subunit analysis
• Aluminum adjuvant content determination
• Detection of process residuals (DOC, CTAB)
• Subvisible particle (aggregate) characterization

Methodology and Instrumentation

A range of analytical platforms was deployed to deliver sensitive and selective measurements:

• LabSolutions DB/CS software for audit trails, user management and secure data archival
• UHPLC‐MS/MS (Nexera LC with LCMS‐8050) for targeted metabolite and saccharide analysis
• MALDI‐TOF MS (AXIMA‐Performance, MALDI‐8020) for rapid protein subunit profiling
• ICP‐OES (ICPE‐9820) and ICP‐MS (ICPMS‐2030) for quantification of aluminum adjuvant
• LC‐MS/MS for simultaneous detection of sodium deoxycholate and cetyl trimethyl ammonium bromide residues
• Aggregates Sizer (SALD‐7500nano) for real‐time subvisible particle size and concentration determination

Main Results and Discussion

• LabSolutions DB/CS ensured 21 CFR Part 11–compliant data security, with audit trails and remote backup/recovery capabilities.
• LC‐MS/MS profiling of cell culture supernatants enabled 95‐component monitoring, revealing key nutrient consumption (e.g., glutamine) and by‐product formation to guide media optimization.
• Simultaneous LC‐MS/MS quantitation of uronic acid, hexose, hexosamine and methylpentose in 23‐valent pneumococcal polysaccharide vaccine achieved high sensitivity, precision (< 1.7% RSD) and matrix tolerance without derivatization.
• MALDI‐TOF MS accurately resolved five viral protein subunits in vaccines, confirming subunit integrity and stoichiometry in formulated product within minutes.
• ICP‐OES and ICP‐MS assays delivered linear quantitation of Al content (R² > 0.9999), with detection limits of 0.90 mg/L and 0.17 mg/L respectively, and recoveries of 107%–116%.
• LC‐MS/MS method for DOC and CTAB residues provided LODs of 1.02 µg/L (DOC) and quantitation of CTAB above 1.56 µg/L, demonstrating high selectivity and minimal carryover.
• Aggregates Sizer analysis showed that mechanical stirring and temperature shifts, especially freeze–thaw cycles, significantly altered particle size distributions and concentrations, underlining critical process control for vaccine stability.

Benefits and Practical Applications

The integrated analytical framework supports:

• Robust electronic record keeping and regulatory audits
• Rapid culture media and process optimization via metabolomic insights
• High‐throughput quality control of polysaccharide and protein vaccines
• Accurate monitoring of adjuvant levels and harmful surfactant residues
• In‐process and end‐product aggregate sizing for safety and immunogenicity assurance

Future Trends and Applications

Emerging directions include:

• Automation and online monitoring for real‐time quality control
• Integration of machine learning for predictive process analytics
• Expansion of high‐resolution MS workflows for complex glycan and protein modifications
• Advanced light‐scattering and imaging approaches for nanoparticle characterization

Conclusion

The combination of secure data management, targeted mass spectrometry, optical emission and particle‐sizing techniques provides a comprehensive toolkit for modern vaccine R&D and manufacturing.
These methods enhance speed, accuracy and robustness of quality assessments, driving safer and more effective vaccines to market.

Použitá instrumentace

• LabSolutions DB/CS Workstation Software
• Nexera UHPLC with LCMS‐8050 Triple Quadrupole MS
• AXIMA‐Performance and MALDI‐8020 MALDI‐TOF MS
• ICPE‐9820 ICP‐OES
• ICPMS‐2030 Inductively Coupled Plasma MS
• SALD‐7500nano Aggregates Sizer

Reference

No references were provided in the original text.