Development of functionally relevant potency assays for monovalent and multivalent vaccines delivered by evolving...

Area of Science:

• Vaccinology
• Biotechnology
• Immunology

Background:

• Potency assays are critical for vaccine lot release and stability monitoring.
• Potency testing verifies the functional integrity and immunocompetence of vaccine antigens.
• Clarity on potency assay definitions and expectations is incomplete, particularly for novel vaccine technologies.

Purpose of the Study:

• To provide a perspective on the purpose, value, and challenges of potency testing for new vaccine technologies.
• To focus on messenger RNA (mRNA) vaccines, drawing parallels with recombinant protein-based vaccines.
• To discuss challenges in developing immunologically relevant in vitro assays for multivalent vaccines.

Main Methods:

• Review and perspective on existing and emerging vaccine potency testing strategies.
• Comparison of potency testing approaches for recombinant protein vaccines versus mRNA vaccines.
• Discussion of assay development challenges, including specificity and cross-reactivity for multivalent products.

Main Results:

• Potency testing is essential for ensuring vaccine efficacy and regulatory compliance.
• Messenger RNA (mRNA) vaccines present unique challenges for potency assessment compared to traditional vaccines.
• Developing specific immunoassays for multivalent vaccines is complex due to potential antigen cross-reactivity.

Conclusions:

• Functional assays correlating with immunogenicity may be acceptable alternatives when specific immunoassays are not feasible.
• Establishing robust assay capabilities at distributed facilities is crucial for rapid global vaccine delivery.
• Addressing challenges in potency testing is vital for the successful deployment of next-generation vaccines, including mRNA platforms.