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.
BS.2251 Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology: Appendix 7. Regulatory assessment of approved rDNA-derived biotherapeutics
BS.2252 Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines
BS.2253 WHO GMP for Biological Products - Proposed replacement of TRS 822, Annex 1
NSB: BS.2268 Guidelines on the stability evaluation of vaccine for use under extended controlled temperature conditions
- WHO Implementation workshop of regulatory expectations and assessment of biotherapeutics in the Africa region, Accra, Ghana, 8-10 September 2015
- Expert Committee on biological Standardization, WHO Headquarters, Geneva, Switzerland, 12-16 October 2015
Technologies Standards and Norms (TSN)
Essential Medicines and Health Products (EMP)
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