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



    • WHO Typhoid Conjugate Vaccine (TCV) Guidelines Drafting Group Meeting, NIBSC, Potters Bar, UK, 25 to 26 November 2019
    • WHO Informal Consultation on Guidelines for assuring the quality, safety and efficacy of DNA vaccines, WHO, Geneva, Switzerland, 9 to 10 December 2019
    • WHO Workshop on implementation of International Standard and assay standardization for Respiratory Syncytial Virus (RSV) vaccines, NIBSC, Potters Bar, UK, 25-27 March 2020