WHO Expert Committee on Biological Standardization : sixtieth report / World Health Organization.

Format:

Book

Author/Creator:

World Health Organization, issuing body.

Contributor:

WHO Expert Committee on Biological Standardization. Meeting, issuing body.

World Health Organization. Expert Committee on Biological Standardization, issuing body.

Series:

Technical report series (World Health Organization) ; 977.

WHO technical report series, 0512-3054 ; 977

Language:

English

Subjects (All):

Biological products--Standards--Congresses.

Biological products.

Drugs--Standards--Congresses.

Drugs.

Physical Description:

1 online resource (241 p.)

Edition:

1st ed.

Place of Publication:

Geneva, Switzerland : World Health Organization, [2013]

Language Note:

English

Summary:

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 i

Contents:

Cover; 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; Blood Regulators Network; Reports from the WHO international laboratories and collaborating centres for biological standards; National Institute for Biological Standards and Control, Potters Bar, England

WHO Collaborating Centre for Quality Assurance of Blood Products and in vitro Diagnostic Devices, Paul-Ehrlich-Institute, Langen, GermanyCenter for Biologics Evaluation and Research (CBER), Food and Drug Administration, Bethesda, USA; Reports from international groups establishing secondary standards; Issues shared with the WHO Expert Committee on Specifications for Pharmaceutical Preparations; Pharmaceutical cold-chain management; Nomenclature of stem cells; International Recommendations, Guidelines, and other matters related to the manufacture and quality control of biologicals

Guidelines for independent lot release of vaccines by regulatory authoritiesGuidelines on evaluation of similar biotherapeutic products (SBPs); Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines; Recommendations to assure the quality, safety and efficacy of live attenuated influenza vaccines; Good manufacturing practices for manufacturing blood products for transfusion; Convalescent plasma; Snake bite envenomings and antivenoms; International reference materials - antigens and related substances; Inactivated poliovirus vaccines (trivalent)

Poliovirus type 1 (Sabin)Human papillomavirus type 16 antibodies; Bordetella pertussis serotype 2 and serotype 3; BCG vaccine; Diphtheria vaccine (adsorbed); International reference materials - blood products and related substances; International Society on Thrombosis and Haemostasis report; Blood coagulation factor VIII, concentrate; Blood coagulation factor VIII and von Willebrand factor (VWF), plasma; Streptodornase; Unfractionated heparin; International reference materials - cytokines, growth factors and endocrinological substances; Chorionic gonadotrophin, human

Parathyroid hormone, 1-84, human recombinantInternational reference materials - diagnostic reagents; HIV-2 RNA; Hepatitis B virus DNA; Parvovirus B19 DNA; Thromboplastin, human, recombinant plain; Soluble transferrin receptor; Prader-Willi and Angelman syndromes; Fusion gene BCR-ABL; Proposed new reference preparation projects; Antigens and related substances; Human papillomavirus (HPV) type 6 DNA and type 11 DNA - proposed International Standards; Purified human genomic DNA; Typhoid antibodies - proposed International Standards

Antibodies (human) to influenza A virus - proposed International Standards

Notes:

"This report contains the collective views of an international group of experts and does not necessarily represent the decision or the stated policy of the World Health Organization"--T.p.

Includes bibliographical references.

Description based on online resource; title from PDF title page (ebrary, viewed September 20, 2014).

ISBN:

92-4-069068-9

OCLC:

893683027