Improving the cellular pertussis vaccine: increased potency and consistency

Area of Science:

• Vaccinology
• Microbial production processes
• Immunology

Background:

• Developing countries predominantly use cost-effective cellular pertussis vaccines.
• Cellular vaccines face challenges with production consistency and potency measurement.
• Standard animal potency tests for pertussis vaccines have limited discriminatory power.

Purpose of the Study:

• To optimize cellular pertussis vaccine production processes for improved consistency and potency.
• To identify and modify critical process steps for enhanced vaccine quality.
• To compare optimized production processes against the original NVP process.

Main Methods:

• Focused on measuring process parameters related to consistency and potency.
• Critically evaluated and modified individual production steps.
• Compared NVP-96 and NVP-THIJS optimized processes with the original NVP process using antigen/biomass content, potency, toxicity, and mouse immunogenicity assays.

Main Results:

• Optimized processes (NVP-96, NVP-THIJS) demonstrated reduced batch-to-batch variation compared to the original NVP process.
• NVP-THIJS showed 15% lower biomass content than NVP-96, with twofold to threefold higher immunogenicity in mice.
• NVP-THIJS exhibited superior stability over 2 years, with comparable potency decline to NVP-96.

Conclusions:

• Optimized production processes significantly improve consistency and immunogenicity of cellular pertussis vaccines.
• The NVP-THIJS process offers a promising approach for producing more stable and effective cellular pertussis vaccines.
• These findings are vital for enhancing vaccine quality in resource-limited settings.