Procedures for the preparation, characterization and establishment of international and other biological reference standards
The procedure for the preparation, characterization and establishment of international and other biological reference standards is based on a number of steps summarized as follows:
- The need for a WHO Biological Reference Material is recognized by scientific and medical community world-wide and a case is formally made by the WHO Secretariat to the Expert Committee on Biological Standardization (ECBS) on the basis of public health impact.
- Working groups of experts are involved in setting the priorities and characteristics for selection of the candidate reference preparations.
- An international collaborative study must be carried out before any candidate reference preparation can be considered for establishment by the WHO ECBS.
- The goal of such a study is to determine which candidate material is suitable to serve as a WHO reference material for the standardization of a biological product or of a in vitro diagnostic tests.tests.
- An internationally agreed unit is attributed to the first WHO Biological Reference Material for biological activity characterization. The continuity of such a unit is ensured by replacement with a new batch of reference material which must be calibrated against the first or previous reference material.
- In all cases such studies must show that the proposed materials are suitable to serve as a WHO Biological Reference Material in terms of stability and reliability of the materials.
- An important requirement to be met by any batch of an WHO Biological Reference Material is that the content in every ampoule in the batch should be identical in terms of composition, quantity, potency and stability.
- The Biological Standardization (BS) document which reports the international multi-method collaborative study is peer-reviewed before being submitted to the WHO ECBS.
- The document supporting the establishment of the WHO Biological Reference Materials (BS doc) is held at WHO and can be obtained on request to the biological programme.
- Established reference materials are held and distributed by the WHO custodian laboratories The recommendations from the ECBS on these preparations are reported in the WHO Technical Report Series (TRS). A catalogue, listing the WHO Biological Reference Materials is available from this Web site.
For further details please consult the WHO Technical Report Series, No. 932, 2006. "Recommendations for the preparation, characterization and establishment of international and other standards" (revised 2004)