Control Strategy Approach for a Well-Characterized Vaccine Drug Product

Area of Science:

• Pharmaceutical Manufacturing
• Vaccine Development
• Quality Risk Management

Background:

• Trumenba (MenB-FHbp; bivalent rLP2086) is a well-characterized meningococcal serogroup B vaccine.
• Manufacturing Trumenba involves complex recombinant protein expression and a suspension formulation, posing challenges for quality attribute control.

Purpose of the Study:

• To describe Pfizer's approach to developing a robust control strategy for Trumenba.
• To ensure consistent product quality and support regulatory requirements through a science- and risk-based methodology.

Main Methods:

• Utilized a control strategy wheel based on International Council for Harmonisation (ICH) guidelines (Q8(R2), Q9, Q10, Q11).
• Determined product quality attribute criticality based on safety and efficacy.
• Assessed process parameter criticality by studying impacts on quality attributes to define controls.

Main Results:

• Developed a control strategy linking product understanding to process controls.
• Implemented specific controls for critical quality attributes of both drug substance and drug product.
• Demonstrated a holistic view of controls through Trumenba case studies.

Conclusions:

• A robust control strategy, built on product and process understanding, is critical for complex pharmaceutical products like Trumenba.
• This approach ensures consistent product quality, facilitates regulatory filings, and supports continuous improvement.