ABSTRACT

Snake antivenoms are polyclonal immunoglobulin preparations obtained from the fractionation of plasma of animals immunized with snake venoms. Currently, the parenteral administration of antivenoms is the keystone for the treatment of snakebite envenomations. Therefore, the development and manufacture of high-quality antivenoms is essential in order to supply safe and effective medicines to envenomated patients. Industrial production of antivenoms is a complex and multi-disciplinary process that comprises different activities, including production of venom and hyperimmune plasma, purification of antivenom immunoglobulins, formulation and stabilization of purified antivenoms, and quality control of in-process and final products. The present chapter discusses an overview of the current technological platform and the most recent efforts involved in the industrial production of antivenoms, including design, manufacture, quality assessment and distribution of antivenoms.