世卫组织生物标准化专家委员会：第七十九次报告
AI智能总结WHO Technical Report Series 1059
WHO Expert Committee on Biological Standardization: Seventy-ninth Report
ISBN: 978-92-4-009797-1 (electronic version)
ISBN: 978-92-4-009798-8 (print version)
ISSN: 0512-3054
Copyright: © World Health Organization 2024
Summary
The World Health Organization (WHO) Technical Report Series 1059, titled "Seventy-ninth report," presents the collective views of an international group of experts who advise WHO on a wide range of medical and public health issues. The report covers several key areas:
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Introduction and Overview
- The report introduces the strategic directions in biological standardization, including updates on recent and planned WHO written standards for biological products.
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General Matters
- Strategic Directions: Updates on the revision of WHO guidelines for blood establishments and the development of guidance on the evaluation of monoclonal antibodies for the prevention or treatment of diseases like COVID-19 and respiratory syncytial virus.
- Cross-cutting Activities: Reports from other WHO committees and groups, including the WHO Product Development for Vaccines Advisory Committee.
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International Recommendations, Guidelines, and Other Matters
- Discontinuation of Innocuity Test: The report notes the discontinuation of the innocuity test.
- Biotherapeutics (excluding Blood Products):
- Nonclinical and clinical evaluation of monoclonal antibodies for preventing or treating COVID-19.
- Development of WHO guidance on the evaluation of monoclonal antibodies for preventing respiratory syncytial virus disease.
- Blood Products and Related Substances: Revision of WHO guidelines on good manufacturing practices for blood establishments.
- Vaccines and Related Substances: Revision of WHO guidelines for ensuring the quality, safety, and efficacy of live attenuated rotavirus vaccines.
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International Reference Materials
- Biotherapeutics (excluding Blood Products):
- First WHO International Standard for golimumab.
- Proposals for new WHO International Standards, including interleukin-2 and endotoxin.
- Proposed discontinuation of the First WHO International Standard for calcitonin ASU 1–7 eel calcitonin analogue.
- Blood Products and Related Substances: Proposals for new WHO International Reference Reagents, such as autoantibodies to ADAMTS13.
- In Vitro Diagnostics:
- First WHO International Reference Panel for Lassa virus RNA for NAT-based assays.
- First WHO International Standard for HIV-1 p24 antigen.
- Proposed new WHO International Standards for carcinoembryonic antigen.
- Biotherapeutics (excluding Blood Products):
Key Points
- Expert Contributions: The report reflects the views of international experts, emphasizing the importance of evidence-based recommendations.
- Scope: The report covers a broad spectrum of biological products, including blood products, vaccines, and biotherapeutics.
- Updates and Revisions: Significant updates include the revision of guidelines for blood establishments, the development of new standards, and the discontinuation of certain tests and standards.
- Collaborative Efforts: The committee's work is part of a larger effort by WHO to improve global health standards and disseminate relevant information.
License: This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO).
Disclaimer: The designations used and the presentation of material in this publication do not imply the expression of any opinion on the part of WHO concerning the legal status of any country, territory, city, or area or of its authorities.
