WHO International biological reference preparations
"To define an internationally agreed unit to allow comparison of biological measurements worldwide"
WHO provides Biological Reference Materials 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, and 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 the 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.
Establishment of WHO Reference Materials
The WHO Biological Reference Materials are established through a standard procedure, found in TRS 932, Annex 2, in which representative materials (often one of several candidates donated to WHO for the purpose) are tested by participating laboratories using their own methodologies. These scientific studies are designed and coordinated by a responsible WHO Collaborating Center. Upon establishment of the reference preparation by the ECBS, the material is assigned a unitage, often in International Units, and serve as the comparator against which results from laboratories, regardless of location or methods employed, can be standardized and compared.
TRS 932 Annex 2
Distribution of WHO Reference Materials
WHO biological reference materials are often in limited supply, and only distributed to qualified laboratories. These include National Control Laboratories and manufacturers of biological medicinal products. The materials are distributed through custodians, which are generally one of the WHO Collaborating Centers. A small handling fee is usually charged by the custodian to offset the costs of international shipments.
Catalogue of WHO Biological Reference Materials
The WHO biological reference materials are listed according to product class, along with identification numbers and custodians.
BS2285 WHO Guidelines on management of blood and blood components as essential medicines
BS2285 Comment Form
BS2280 Labelling information of inactivated Influenza vaccines for use in pregnant women
BS2280 Comment Form
BS2283 WHO Guidelines on estimation of residual risk of HIV, HBV or HCV infections via cellular blood commponents and plasma
BS2283 Comment Form
BS2284 WHO Manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: Calibration to WHO International Standards
BS2284 Comment Form
BS2279 Guidelines on the quality, safety and efficacy of Ebola vaccines
BS2279 Comment Form
BS2287 Guidelines on Clinical evaluation of vaccines: regulatory expectations
BS2287 Comment Form
BS2288 Human Challenge Trials: scientific and regulatory considerations
BS2288 Comment Form
BS2289 Guidelines on regulatory preparedness for licensing human pandemic influenza vaccines in non-vaccine-producing countries
BS2289 Comment Form
BS2290 Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs)
BS2290 Comment Form
- Expert Committee on Biological Standardization (ECBS) 17 - 21 October 2016
Technologies Standards and Norms (TSN)
Essential Medicines and Health Products (EMP)
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