Quality by design for a vaccine release immunoassay: a case study

Area of Science:

• Pharmaceutical Science
• Vaccinology
• Analytical Chemistry

Background:

• Quality by Design (QbD) principles are increasingly applied to analytical method development in pharmaceutical product lifecycles.
• This study focuses on applying QbD to antigenicity assays for a quadrivalent vaccine candidate.

Purpose of the Study:

• To develop antigenicity assays using a Quality by Design (QbD) approach.
• To measure the in vitro relative potency of a quadrivalent vaccine candidate.

Main Methods:

• Utilized statistical design of experiments (DOE) for method optimization and establishing a design space.
• Conducted systematic risk analysis to identify and mitigate potential risks to method performance.
• Developed immunoassays aligned with customer-defined development targets.

Main Results:

• Successfully optimized immunoassay parameters within a defined design space.
• Identified and mitigated critical risks affecting assay performance through QbD strategies.
• Established control strategies to ensure consistent method performance.

Conclusions:

• QbD-based method development offers a more efficient and systematic approach compared to traditional methods.
• This QbD methodology has the potential to facilitate smoother assay transfers and simplify lifecycle management.
• The developed antigenicity assays provide reliable measurement of vaccine candidate potency.