WHO Expert Committee on Biological Standardization : fifty-second report.

Format:

Book

Conference/Event

Government document

Author/Creator:

WHO Expert Committee on Biological Standardization. Meeting (52nd : 2001 : Geneva, Switzerland)

Contributor:

World Health Organization.

Conference Name:

WHO Expert Committee on Biological Standardization. Meeting (52th : 2001 : Geneva, Switzerland.)

Series:

Technical report series (World Health Organization) ; 924.

WHO technical report series, 0512-3054 ; 924

Language:

English

Subjects (All):

Biological products--Standards--Congresses.

Biological products.

Drugs--Standards--Congresses.

Drugs.

Physical Description:

1 online resource (244 p.)

Edition:

1st ed.

Place of Publication:

Geneva : World Health Organization, 2004.

Language Note:

English

Summary:

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international requirements 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 CommitteeÆs attention and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national control authorities, contains recommendations for the production and control of oral poliomyelitis vaccine, an amendment to the requirements for meningococcal polysaccharide vaccine, and a decision-tree for setting priorities in the development of reference materials. Also included are guidelines for the preparation, characterization, and establishment of standards and reference reagents for biological substances.

Contents:

505 0 Introduction

General. Developments in biological standardization. Bioterrorism. International nonproprietary names for biotechnology-derived medicinal products

International guidelines, recommendations, and other matters related to the manufacture and quality control of biologicals. Guidelines on clinical evaluation of vaccines: regulatory expectations. Group C meningococcal conjugate vaccines. Inactivated oral cholera vaccines. Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. Pneumococcal conjugate vaccines. Potency assays for diphtheria and tetanus vaccines. Pertussis vaccines. Preventive human immunodeficiency virus vaccines. Cell substrate safety. Cell banks. Yellow fever. Poliomyelitis vaccine, oral. Transmissible spongiform encephalitis and the safety of biologicals. Antivenoms. Gene therapy. Discontinuation requirements

International reference materials. Biological substances: international standards and reference reagents. International biological standards for in vitro diagnostic procedures. International reference materials for the diagnosis and study of transmissible spongiform encephalitis

Antibodies. Human antibody against human platelet antigen 5b

Blood products and related substances. International reference panels for the validation of serological and nucleic acid based test for the detection of hepatitis B, hepatitis C and human immunodeficiency virus in blood screening. Factors II, VII, X, plasma. Von Willebrand factor. Streptokinase. Unfractioned heparin and low-molecular-weight heparin

Cytokines, growth factors and endocrinological substances. Human chorionic gonadotrophin. Ciliary neurotrophic factor. Prolactin and its glycosylated and non-glycosylated components

Miscellaneous. Pertussis toxin standard

Annex 1. Guidelines on clinical evaluation of vaccines: regulatory expectations

Annex 2. Recommendations for the production and control of meningococcal group C conjugate vaccines

Annex 3. Guidelines for the production and control of inactivated oral cholera vaccines

Annex 4. Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood products

Annex 5. Biological substances: international standards and reference reagents

Annex 6. Recommendations and guidelines for biological substances used in medicine and other documents.

Notes:

"The WHO Expert Committee on Biological Standardization met in Geneva from 26 to 30 November 2001"--Introd.

Includes bibliographical references.

ISBN:

1-280-09743-4

9786610097432

92-4-068152-3

OCLC:

559332398