Availability and use of Standards in vaccine development

Area of Science:

• Vaccinology
• Immunology
• Biotechnology

Background:

• Reference materials are essential for calibrating assays in vaccine development.
• The COVID-19 pandemic highlighted the need for robust immunoassay standards to assess vaccine responses.
• Standards are also critical for controlling vaccine manufacturing processes and ensuring product quality.

Purpose of the Study:

• To advocate for the incorporation of reference materials and calibration to International Standards throughout the vaccine development lifecycle.
• To emphasize the necessity of standardized assays for a successful Chemistry, Manufacturing, and Controls (CMC) strategy.
• To inform about the availability of World Health Organization (WHO) international antibody standards for CEPI-priority pathogens.

Main Methods:

• This perspective paper reviews the critical role of reference materials in assay development.
• It discusses the importance of calibrating assays to International Standards.
• It highlights the availability of specific WHO international antibody standards.

Main Results:

• Standardized assays and reference materials are necessary for reliable vaccine characterization.
• Incorporating reference materials from preclinical development through control testing is essential.
• WHO international antibody standards are available for specific pathogens.

Conclusions:

• Adoption of reference materials and international standards is vital for robust vaccine development and manufacturing.
• Standardization ensures accurate assessment of vaccine efficacy and manufacturing consistency.
• Availability of WHO standards supports global efforts in vaccine development for priority pathogens.