WHO Expert Committee on Biological Standardization
Fifty-ninth Report
Technical Report Series, No 964
World Health Organization
ISBN-13    9789241209649 ISBN-10    924120964X
Order Number    11000964 Format    Paper Back
Price    CHF    50.00 / US$    60.00 Developing countries:    CHF    35.00
English     2012        236   pages
Summary
Table of contents
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Table of contents
Introduction
General
Strategic directions in biological standardization
Vaccines and biological therapeutics: recent and planned activities in biological standardization
Blood products and related in vitro diagnostics: recent and planned activities in biological standardization
Reports from the WHO International Laboratory and Collaborating Centres for Biological Standards
Scientific issues identified by users of WHO biological reference preparations
Joint session with the Expert Committee on Specifications for Pharmaceutical Preparations
Quality control parameters and their relevance to WHO International Standards
International recommendations, guidelines, and other matters related to the manufacture and quality control of biologicals
Recommendations for Yellow vaccine
Abbreviated licencing pathways for certain biological therapeutic products
Poliovirus vaccines
Guidelines for Lot Release of Vaccines
Priorities for work on new or revised recommendations or guidelines for vaccines
Nomenclature for biological medicines: vaccine abbreviations
Production, control and regulation of snake anti-venom immunoglobulins
Selection of venoms and preclinical assessment of antivenom immunoglobulins
Need for regulation of blood products in developing countries
International reference materials
Antibiotics
Gramicidin, 2nd International Standard
Antigens and related substances
Influenza H5N1 antibody (human), 1st International Standard
Human papillomavirus type 16 DNA, 1st International Standard
Human papillomavirus type 18 DNA, 1st International Standard
Rabies vaccine, 6th International Standard
Acellular Pertussis vaccine, 1st International Standard for potency assay by Modified Kendrick Test
Pertussis antiserum (human), 1st International Standard
Blood products and related substances
Anti-hepatitis B surface antigen (anti-HBs) immunoglobulin, human, 2nd International Standard
Blood coagulation factor IX, concentrate, 4th International Standard
Factor VIIa concentrate, 2nd International Standard
Parvovirus B19 DNA, plasma, human, 2nd International Standard
Anti-A and anti-B antibodies in intravenous immunoglobulin, human, WHO reference reagents
Anti-hepatitis B core antigen (anti-HBc), plasma, human, 1st International Standard
Alpha-1-antitrypsin; assignment of a total protein and antigenic concentration to the 1st International Standard, and extension of its use to assign potencies to recombinant products
Cytokines, growth factors and endocrinological substances
Insulin-like growth factor (IGF-1), 1st International Standard
Diagnostic reagents
Haemophilia A intron 22 inversion, 1st reference panel for molecular genetic diagnosis
Fragile X syndrome, 1st reference panel for molecular genetic diagnosis
Proposed new reference preparation projects
Annex 1: Addendum to Requirements for yellow fever vaccine
Annex 2: Guidelines for the production, control and regulation of snake antivenom immunoglobulins
Annex 3: Biological substances - International Standards and Reference Reagents
Annex 4: Recommendations and guidelines for biological substances used in medicine and other documents