Biological medicinal products differ from chemical drugs in that they cannot normally be characterized molecularly; starting methods such as bacteria, viruses, or genetically modified micro-organisms are of enormous complexity, as well as having the capacity to vary from preparation to preparation. A certain amount of these products, such as vaccines against transmissable disease, are also administered to healthy individuals -- often children at the start of their lives, and thus a strong emphasis must be placed on their quality to ensure, to the greatest extent possible, that they are efficacious in preventing or treating life-threatening disease, without themselves causing harm.
The increasing globalization in the production and distribution of these biological medicines has opened new possibilities to better manage public health concerns, but has also raised questions about the equivalence and interchangeability of medicines procured across a variety of sources. International standardization of starting materials, of production and quality control testing, and the setting of high expectations for regulatory oversight on the way these products are manufactured and used have thus been the cornerstone for their continued success. But it remains a field in constant change. The continuous technical advances in the field offer a promise of developing potent new weapons against our oldest public health threats, as well as new ones - malaria, genetic deficiencies, pandemic influenza, and AIDS, to name a few -- but also put a great pressure on manufacturers, regulatory authorities, and the wider medical community to ensure that products continue to meet the highest standards of quality attainable.
Production and Quality: WHO Specifications
Biological medicinal products, such as vaccines, blood and blood products, diagnostics, gene therapy, biotechnology products, cytokines and growth factors, and cell and tissue products rely heavily on international standardization to ensure their quality and their equivalence across manufacturers. For over a half-century, WHO has been active in the field of biological standardization, bringing together scientists and policy makers on a global scale to find consensus approaches to the manufacturing, testing and regulatory oversight of these medicinal products. Through the WHO Technical Report Series (TRS) up-to-date methods are described for the benefit of its Member States and manufacturers, and international reference materials for the standardization of assays and testing are established through collaborative studes for global distribution. Consultations and expert working groups on technical issues important to the field are also documented, giving interested parties the latest information available on complex issues such as biocontainment of potential pandemic threats, clinical and non-clinical testing of vaccines, risks of transmissible spongiform encephalopathies (TSE's), DNA vaccines, and a variety of other topics.
VACCINES AND IMMUNIZATION PRACTICES
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
- Expert Committee on Biological Standardization, WHO Headquarters, Geneva, Switzerland, 12-16 October 2015
Technologies Standards and Norms (TSN)
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