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 .
The beneficial impact of biologicals is as diverse as the types of products themselves:
Vaccines are one of the most powerful and cost-effective ways to reduce the global burden of disease and are estimated to save 2–3 million lives every year. Some diseases, such as smallpox and two types of polio, have been eradicated thanks to global efforts to vaccinate and control their spread. However, as many transmissible diseases continue to claim millions of lives annually, the development of new vaccines and other biological products, and new methods to improve their quality, potency, safety and efficacy, remain major challenges in the field of public health.
Blood products are life-saving products used extensively during surgery, in patients with traumas, or those with bleeding disorders, and in people undergoing chemotherapy for the treatment of cancer. Most donated blood is fractioned into its separate components so a single unit may be used to help multiple patients in need.
There are numerous other biological therapeutics, such as insulin used in the treatment of diabetes, interferons for viral infections and cancer therapy, monoclonal antibodies that are also used in the treatment of some cancers or autoimmune diseases. This class of agent also includes stem cells and some gene therapies.
Together, these products are major human achievements and compelling examples of the power of biologicals in medicine.
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.