WHO works with Member States, Collaborating Centres, partners and experts through its biological standardization programme to develop and revise guidance on biotherapeutic products and to establish international reference standards. The guidelines produced are promoted through their publication on the WHO website, as well as through workshops and training sessions to facilitate their implementation. This outreach has proved valuable in promoting WHO recommendations that promote international harmonization of guidance for biological therapeutics.
Similarly, the development and promotion of WHO international reference standards helps ensure that biological therapeutics are standardized between different manufacturers, countries, and laboratories. They are used extensively in ensuring the quality and efficacy of biologicals, as well as in the calibration of diagnostic tests.
Several key programs reflect the importance WHO places on biological medicines as powerful agents to reduce the global burden of disease. These include the Global Vaccine Action Plan (GVAP) and the Blood Regulators Network (BRN), which is comprised of leading international authorities on blood, blood products and in vitro diagnostic devices. WHO also celebrates World Immunization Week each April, with associated events aimed at promoting the use and understanding of vaccines and combat vaccine hesitancy around the world
Biologicals
Biological therapeutics, also referred to as Biologicals, are those class of medicines which are grown and then purified from large-scale cell cultures of bacteria or yeast, or plant or animal cells. Biologicals are a diverse group of medicines which includes vaccines, growth factors, immune modulators, monoclonal antibodies, as well as products derived from human blood and plasma. What distinguishes biologicals from other medicines is that these are generally proteins purified from living culture systems or from blood, whereas other medicines are considered as ‘small molecules’ and are either made synthetically or purified from plants.
Due to the differences in their nature and how they are produced, biological therapeutics are regulated, tested, and controlled differently than other medicines. To help ensure their quality, safety, and efficacy, each batch of a biological therapeutic product must be tested extensively at each stage of production in order to ensure consistency with prior batches. The use of WHO international reference standards helps to further ensure the consistency of a product across many batches as well as to allow the comparability of biologicals between manufacturers and/or countries. The establishment of general requirements applicable across a diverse range of product classes governing starting materials, manufacturing and regulatory oversight is an essential aspect of this process. Whereas guidelines may be established for specific biologicals to help .
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