WHO International biological reference preparations

Role

"To define an internationally agreed unit to allow comparison of biological measurements worldwide"

WHO provides International Biological Reference Preparations which serve as reference sources of defined biological activity expressed in an internationally agreed unit.

These preparations are the basis of a uniform reporting system, helping physicians and scientists involved in patient care, regulatory authorities and manufacturing settings to communicate in a common language for:

• designating the activity or potency of biological preparations used in prophylaxis or therapy
• ensuring the reliability of in vitro biological diagnostic procedures used for diagnosis of diseases and treatment monitoring

This concept of using well-characterized preparations as references against which batches of biological products are assessed remains fundamental to ensuring the quality of biological products as well as the consistency of production and are essential for establishment of appropriate clinical dosing. These preparations are generally intended for use in the characterization of the activity of secondary reference preparations (regional, national or in-house working standards). They are made for use in laboratory assays only and should not be administered to humans.

NEW ! For Public Comment by 9 October 2009
BS/09.2108-Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines
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NEW ! For Public Comment by 9 October 2009
BS/09.2109-Guidelines for Independent Lot Release of Vaccines by Regulatory Authorities
Download [pdf 222kb]

NEW ! For Public Comment by 9 October 2009
BS/09.2110-Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)
Download [pdf 279kb]

NEW! Request for Proposal - Submission of proposals by 28 September, 2009
Production of Sabin Poliovirus Master and Working Seeds to Ensure Future Production of both Live and Inactivated Polio Vaccines
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Meeting Report-WHO Workshop in Training Performance of Potency Testing and Lot Release of Human Papillomavirus (HPV) Vaccines
NIBSC, UK, 11-15 May 2009
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Further H1N1 specific update of TRS 941, Annex 5
Download [pdf 145kb]

H1N1 specific-update of TRS 941, Annex 5
Download [pdf 162kb]

ECBS 2008 Outcomes
Download [pdf 37kb]

Proposed Guidelines: Regulatory Preparedness for Human Pandemic Influenza Vaccines
Download [pdf 690kb]

WHO Informal Consultation on Standardization and Evaluation of BCG Vaccines
22-23 September 2009, Geneva, Switzerland

WHO Informal Consultation on Acellular pertussis vaccine and DTP based combined Vaccines
9-13 November 2009, Geneva, Switzerland