WHO Expert Committee on Biological Standardization.

WHO Expert Committee on Biological Standardization.

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. Th...

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Bibliographic Details
Main Author: Organization, World Health
Format: eBook
Language:English
Published: Geneva : World Health Organization, 2013.
Series:Technical report series (World Health Organization)
Subjects:
Biological products > Standards > Congresses.
Drugs > Standards > Congresses.
MEDICAL > Pharmacology.
Biological products > Standards
Drugs > Standards
Conference papers and proceedings
Online Access:Click for online access
Table of Contents:
  • Cover; Contents; Abbreviations; 1. Introduction; 2. General; 2.1 Current directions; 2.1.1 Strategic directions in biological standardization; 2.1.2 Vaccines and biological therapeutics: recent and planned activities in biological standardization; 2.1.3 Blood products and related in vitro diagnostics: recent and planned activities in biological standardization; 2.2 Reports; 2.2.1 WHO Blood Regulators Network; 2.2.2 Reports from the WHO international laboratories and collaborating centres for biological standards; 2.3 Issues.
  • 2.3.1 Scientific issues identified by users of WHO biological reference preparations2.3.2 Issues shared with the WHO Expert Committee on Specifications for Pharmaceutical Preparations; 3. International Recommendations, Guidelines and other matters related to the manufacture and quality control of biologicals; 3.1 Vaccines and related substances; 3.1.1 Guidelines for independent lot release of vaccines by regulatory authorities.
  • 3.1.2 Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks3.1.3 Recommendations to assure the quality, safety and efficacy of hepatitis B vaccines; 3.1.4 Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines; 3.1.5 Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies; 3.2 Blood products and related substances; 3.2.1 GMP for blood establishments.
  • 3.2.2 WHO tables on tissue infectivity distribution in TSEs3.2.3 Assessment criteria for national blood regulatory systems; 4. International reference materials
  • vaccines and related substances; 4.1 WHO International Standards and Reference Reagents
  • vaccines and related substances; 4.1.1 Antibody to vaccinia virus; 4.1.2 Antibody to pandemic H1N1 influenza virus; 4.1.3 Tetanus vaccine; 4.1.4 BCG vaccine; 4.2 Proposed new projects
  • vaccines and related substances; 4.2.1 Diphtheria vaccine for calibration of formulated products by alternative to challenge assays (Vero cell assay).
  • 4.2.2 Hepatitis B vaccine4.2.3 BCG vaccine of Moreau substrain; 4.3 Ongoing stability monitoring
  • vaccines and related substances; 4.3.1 Tetanus toxoid, flocculation; 5. International reference materials
  • blood products and related substances; 5.1 WHO International Standards and Reference Reagents
  • blood products and related substances; 5.1.1 Thrombosis and haemostasis; 5.1.2 Antithrombin, plasma; 5.1.3 Factors II, VII, IX and X, plasma; 5.1.4 Von Willebrand factor, concentrate; 5.1.5 C1 inhibitor, plasma and C1 inhibitor, concentrate.
  • 5.2 Proposed new projects
  • blood products and related substances.

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