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.

WHO HPV LabNet - Newsletter 05
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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
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H1N1 specific-update of TRS 941, Annex 5
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Proposed Guidelines: Regulatory Preparedness for Human Pandemic Influenza Vaccines
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2010 WHO Human Papillovavirus (HPV) laboratory network (LabNet) Training Workshop on HPV Genotyping and HPV Serology Laboratory Performance
15-18 March 2010, CHUV, Lausanne, Switzerland

Informal Consultation on Revision of WHO Recommendations to assure the Quality, Safety of Efficacy of Yellow Fever Vaccines
27-28 April 2010, WHO, Geneva, Switzerland