Technical Report Series articles from May 2005

Technical Report Series archives from May 2005

Introduction.(World Health Organization Expert Committee on Biological Standardization meeting)(Brief Article)
May 1, 2005... The WHO Expert Committee on Biological Standardization met in Geneva from 17 to 21 February 2003. Dr Asamoa-Baah, Executive Director of the Health Technology and Pharmaceuticals cluster at WHO, opened the meeting on behalf of the...

General.(World Health Organization activities)
May 1, 2005... Developments in biological standardization Progress in the spheres of activity of the WHO units responsible for biological standardization (Quality Assurance and Safety of Biologicals and Quality Assurance and Safety of Plasma...

International recommendations, guidelines and other matters related to the manufacture and quality control of biologicals.
May 1, 2005... Recommendations for the production and quality control of smallpox vaccine The Committee reviewed the draft Recommendations for production and control of smallpox vaccine (BS/03.1954), prepared as an update of the Requirements for...

International reference standards.(Recommendations for the preparation, characterization and establishment of international and other biological reference standards)(Brief Article)
May 1, 2005... Recommendations for the preparation, characterization and establishment of international and other biological reference standards. The Committee was informed that a proposed revision of the current Guidelines for preparation,...

Antibodies.(anti-parvovirus B19 plasma and anti-human platelet antigen 5b)
May 1, 2005... The Committee noted inconsistencies in the designation and activity assignment to antibody reference materials and requested the Secretariat to investigate this issue and make proposals for amendments at a future meeting. Anti-parvovirus...

Antigens and related substances.(flaviviruses antibodies )(Brief Article)
May 1, 2005... Flavivirus reference materials The Committee received a report on progress towards the preparation of reference materials for flaviviruses. In the past the results of cell-based assays for yellow fever vaccine had not correlated with data...

Blood products and related substances.(stocks and development of International Standards)
May 1, 2005... Anti-D immunoglobulin The Committee was informed that the existing International Standard had been found positive for hepatitis C virus and should be replaced. The Committee was also informed that stocks of the US Standard were almost...

Cytokines, growth factor and endocrinological factors.(standard for Erythropoietin and news about reference preparations for interferon beta)(Brief Article)
May 1, 2005... Erythropoietin The Committee was informed that stocks of the first International Standard for Erythropoietin, recombinant, are almost exhausted. A number of preparations had been included in the collaborative study on the basis of which...

Diagnostic reagents.(lipoprotein, CJD prions and synthetic target nucleic acids as candidate reference materials)
May 1, 2005... Lipoprotein (a) The Committee was informed that the presence of high levels of lipoprotein (a) is a genetically determined marker of predisposition to coronary heart disease. Because accurate measurement of lipoprotein (a) is important...

Miscellaneous.(poliovirus vaccines and Papillomavirus reference materials)
May 1, 2005... Mutant analysis by polymerase chain reaction and restriction enzyme cleavage assays for poliovirus The Committee was informed that a single base change in poliovirus type 2 was associated with an increase in neurovirulence. A mutant...

Recommendations (a) for the production and quality control of smallpox vaccine, revised 2003.(Annex 1)
May 1, 2005... Recommendations published by WHO are intended to be scientific and advisory. Each of the following sections constitutes guidance for national regulatory authorities and for the manufacturers of biological products. If a national regulatory...

Guidelines for the safe production and quality control of inactivated poliomyelitis vaccine manufactured from wild polioviruses (addendum, 2003, to the recommendations for the production and quality control of poliomyelitis vaccine (inactivated)).(Annex 2)
May 1, 2005... The WHO Recommendations for the Production and Quality Control of Poliomyelitis Vaccine (Inactivated) were last revised in 2000. At that time it was envisaged that the production and quality control of inactivated poliomyelitis vaccine (IPV)...

Recommendations for the production and control of group C meningococcal conjugate vaccines: (Addendum 2003).(Annex from the National Institute for Biological Standards and Control)
May 1, 2005... At its fifty-second meeting the Expert Committee on Biological Standardization adopted the Recommendations for the production and control of group C meningococcal conjugate vaccines, which were published in its report (1). The Committee...

Guidelines on regulatory expectations related to the elimination, reduction or replacement of thiomersal in vaccines.(World Health Organization)
May 1, 2005... Introduction Thiomersal (also known as thimerosal, merthiolate) is an organomercurial derivative of ethylmercury that has been used very widely, and for a very long time, as a preservative in vaccines in their final bulk formulations....

Biological substances: international standards and reference reagents.(World Health Organization)
May 1, 2005... A list of International Biological Standards, International Biological Reference Preparations and International Biological Reference Reagents was issued in WHO Technical Report Series 897, 2000 (Annex 4) and is available on the Internet at...

Recommendations and guidelines for biological substances used in medicine and other documents.(World Health Organization)(Bibliography)
May 1, 2005... The recommendations (previously called requirements) and guidelines published by the World Health Organization are scientific and advisory in nature but may be adopted by a national regulatory authority as national requirements or used as the...