2024-10-17-世界卫生组织-Main_outcomes_of_the_meeting_of_the_WHO_Expert_Committee_on_Biological_Standardization_held_from_7_to_11_October_2024_3页_90kb

WHO Expert Committee on Biological Standardization Meeting Summary

The 80th meeting of the WHO Expert Committee on Biological Standardization (ECBS) was held from October 7 to 11, 2024. Key outcomes included recommendations for adopting three WHO documents and establishing eight new international reference materials, while discontinuing two existing ones.

Main Recommendations:

• Adopted WHO Documents:
  • Guidance on nonclinical and clinical evaluation of RSV monoclonal antibodies for disease prevention.
  • Recommendations to assure quality, safety, and efficacy of rotavirus vaccines, now more broadly applicable.
  • Good practices for blood establishments, replacing the 2011 guidelines.
• International Reference Materials Established:
  • For in vitro diagnostics: Epidermal growth factor receptor variants, serum amyloid A, thyroglobulin antibodies (human serum), and tissue transglutaminase autoantibodies.
  • For vaccines: Marburg virus antibodies and SARS-CoV-1 antibodies for neutralization assays.
• Discontinued Materials:
  • First WHO International Standard for calcitonin and human C-reactive protein due to low demand.
• Proposed Actions: The ECBS endorsed seven proposals for future reference materials and welcomed initiatives to replace animal-based assays with non-animal alternatives.

Key Discussions:

• Importance of harmonizing clinically critical assays globally for patient treatment decisions.
• Prioritizing WHO guidance development for biological products, emphasizing transparency and global need.
• Ongoing efforts to reduce animal testing in vaccine and biotherapeutic quality control.

The next meeting is scheduled for October 13–17, 2025. Further details will be included in the final report to be published in the WHO Technical Report Series in 2025.