WHO Guidelines for the Production, Control and Regulation of Snake Antivenom Immunoglobulins
(2010; 141 pages)


These Guidelines were adopted by the WHO Expert Committee on Biological Standardization at its 59th meeting which took place in Geneva from 13 to 17 October 2008 and will be published in the WHO Technical Report Series. The unavailability of effective snake antivenom immunoglobulins (antivenoms) to treat the specific types of snakebite envenomings encountered in various regions of the world has become a critical health issue at global level. The crisis has reached its greatest intensity in sub-Saharan Africa, but other regions, such as south-east Asia, are also suffering from a lack of effective and affordable products.

The complexity of the production of antivenoms, in particular the importance of preparing appropriate snake venom mixtures for the production of hyperimmune plasma (the source of antivenom immunoglobulins), the decreasing number of producers and the fragility of the production systems in developing countries further jeopardize the availability of effective antivenoms in Africa, Asia, the Middle East and South America. Most of the remaining current producers are located in countries where the application of quality and safety standards needs to be improved...

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