Guidelines for the production, control and regulation of snake antivenom immunoglobulins, Annex 5, TRS No 1004

Overview

Snake antivenom immunoglobulins (antivenoms) are the only therapeutic products for the treatment of snake-bite envenoming. The lack of availability of effective snake antivenom immunoglobulins to treat envenoming by medically
important venomous snakes 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 and South-East Asia, are also suffering from a lack of effective and affordable products.

The first edition of the WHO Guidelines for the production, control and regulation of snake antivenom immunoglobulins was developed in response to the above-mentioned needs and approved by the WHO Expert Committee on
Biological Standardization in October 2008. These Guidelines covered all the steps involved in the production, control and regulation of venoms and antivenoms. It is intended that these updated Guidelines, by comprehensively describing the current existing experience in the manufacture, preclinical and clinical assessment of these products, will serve as a guide to national regulatory authorities (NRAs) and manufacturers in support of worldwide production of these essential medicines. The production of snake antivenoms following good manufacturing practices (GMP) should be the aim of all countries involved in the manufacture of these life-saving biological products.

It should however be recognized that some sections, such as: those dealing with immunogen quality control, reference materials, and the production, purification and testing of antibodies (sections 10–19); as well as most of the guidance which deals with regulatory oversight (section 21); and the ethical use of laboratory animals and plasma donor animals (section 4); may also apply to other types of antivenoms, such as those produced for the treatment of envenoming caused by spiders, scorpions and other organisms. There are also other immunoglobulin products of animal origin for which some of the production methodologies described here may be similar or identical – for example, the selection and veterinary health care of animals; immunization regimens and use of adjuvants; collection and control of animal plasma for fractionation; purification of immunoglobulins; and control of infectious risks. These WHO Guidelines may
therefore have application beyond providing information for the production of snake antivenom immunoglobulins, and may be applicable also to other antivenoms or animal-derived immunoglobulin products (for example, equine-derived botulism antitoxins).