Standardization of Biotherapeutic Products

The World Health Organization brings together international experts through its biological standardization programme to develop and revise guidance on biotherapeutic products. The norms and standards programme for biotherapeutics is responsible for developing and establishing both international biological reference preparations and written standards (Recommendations and Guidelines) for these products. The promotion of WHO biological standards is undertaken in a variety of ways including rapid publication on the WHO website, as well as by the organization of post-adoption workshops to facilitate the implementation of highly complex or topical guidelines/recommendations into regulatory and manufacturers’ practice. Such workshops have proved extremely valuable not only in promoting the WHO recommendations/guidelines in question, but also as a means of obtaining information from countries about their use of WHO guidance documents and their ability to follow WHO guidance, as well on interpreting difficult aspects of the guidance given in the documents.

Biotherapeutic-specific standardization

General topics and regulatory guidance



TRS 1004 - WHO Expert Committee on Biological Standardization, Sixty-seventh report


  • WHO Working Group meeting on Respiratory Syncytial Virus (RSV) Vaccine Standardization, WHO headquarters, Geneva, Switzerland, 13-15 September 2017
  • WHO Second Working Group Meeting on Developing WHO Guidelines on safe production of polio vaccines, WHO HQ Salle D, 19-20 September 2017
  • WHO Workshop on Implementation of Good Manufacturing Practices for Biological Products, Bangkok, Thailand 15-17 November 2017
  • WHO Implementation Workshop on the Quality, Safety and Efficacy of Typhoid Conjugate Vaccines, Osong, Chungju-si, The Republic of Korea, 21-13 November 2017


Technologies Standards and Norms (TSN)
Essential Medicines and Health Products (EMP)
World Health Organization (WHO)
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