WHO Expert Committee on Biological Standardization: 60th Report
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.

The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO recommendations for production and control of live attenuated influenza vaccines and for production and control of pneumococcal conjugate vaccines. New WHO guidelines on the regulatory evaluation of similar biotherapeutic medicines are also provided.

Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.
1116797783
WHO Expert Committee on Biological Standardization: 60th Report
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.

The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO recommendations for production and control of live attenuated influenza vaccines and for production and control of pneumococcal conjugate vaccines. New WHO guidelines on the regulatory evaluation of similar biotherapeutic medicines are also provided.

Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.
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WHO Expert Committee on Biological Standardization: 60th Report

WHO Expert Committee on Biological Standardization: 60th Report

by World Health Organization
WHO Expert Committee on Biological Standardization: 60th Report

WHO Expert Committee on Biological Standardization: 60th Report

by World Health Organization

Overview

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.

The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO recommendations for production and control of live attenuated influenza vaccines and for production and control of pneumococcal conjugate vaccines. New WHO guidelines on the regulatory evaluation of similar biotherapeutic medicines are also provided.

Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.

Product Details

ISBN-13: 9789241209779
Publisher: World Health Organization
Publication date: 04/07/2014
Series: WHO Technical Report Series , #977
Pages: 240
Product dimensions: 6.25(w) x 9.50(h) x 0.60(d)

About the Author

World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.

Table of Contents

Introduction 1

General 2

Strategic directions in biological standardization 2

Vaccines and biological therapeutics: recent and planned activities in biological standardization 3

Blood products and related in vitro diagnostics: recent and planned activities in biological standardization 3

Blood Regulators Network 5

Reports from the Who international laboratories and collaborating centres for biological standards 5

Reports from international groups establishing secondary standards 5

Issues shared with the Who Expert Committee on Specifications for Pharmaceutical Preparations 9

International Recommendations, Guidelines, and other matters related to the manufacture and quality control of biologicals 10

Guidelines for independent lot release of vaccines by regulatory authorities 10

Guidelines on evaluation of similar biotherapeutic products (SBPs) 10

Recommendations to assure the quality, safety and efficacy of live attenuated influenza vaccines 11

Recommendations to assure the quality, safety and efficacy of live attenuated influenza vaccines 11

Good manufacturing practices for manufacturing blood products for transfusion 12

Convalescent plasma 12

Snake bite envenomings and antivenoms 13

International reference materials - antigens and related substances 14

Inactivated poliovirus vaccines (trivalent) 14

Pollovirus type 1(Sabin) 14

Human papiliomavirus type 16 antibodies 15

Bordetella pertussis serotype 2 and serotype 3 16

BCG vaccine 16

Diphtheria vaccine (adsorbed) 17

International reference materials - blood products and related substances 19

International Society on Thrombosis and Haemostasis report 19

Blood coagulation factor VIII, concentrate 19

Blood coagulation factor VIII and von Willebrand factor (VWF), plasma 20

Streptodornase 21

Unfractionated heparin 22

International reference materials - cytokines, growth factors and endocrinological substances 24

Chorionic gonadotrophin, human 24

Parathyroid hormone, 1-84, human recombinant 24

International reference materials - diagnostic reagents 26

HIV-2 RNA 26

Hepatitis B virus DNA 27

Parvovirus B19 DNA 28

Thromboplastin, human, recombinant plain 30

Soluble transferrin receptor 31

Prader-Willi and Angelman syndromes 32

Fusion gene BCR-ABL 33

Proposed new reference preparation projects 35

Antigens and related substances 35

Blood products and related substances 37

Cytokines, growth factors and endocrinological substances 39

Diagnostic reagents 40

Ongoing stability monitoring for Who international standards 46

Annex 1 Recommendations, Guidelines and other documents for biological substances used in medicine 47

Annex 2 Guidelines on evaluation of similar biotherapeutic products (SRPs) 51

Annex 3 Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines 91

Annex 4 Recommendations to assure the quality, safety and efficacy of influenza vaccines (human, live attenuated) for intranasal administration 153

Annex 5 Biological substances - International Standards and Reference Reagents 229

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