Development of Target Product Profiles for Snake Antivenom Products


  • Dr Bernadette Abela-Ridder

    World Health Organization, Switzerland, Switzerland

Project summary

Antivenoms are bespoke biologicals that have been the mainstay of snakebite treatment for 125 years. Requirements for production, safety and efficacy vary across regulatory environments. Shortages of effective antivenoms have emerged as important public health issues, particularly in Sub-Saharan Africa. The variability of current products in this market present substantial challenges. WHO is exploring a pathway for prequalification of antivenoms and identified a need to develop target product profiles (TPPs) to support optimisation of current and emerging products. TPPs can play a central role in the drug discovery and development process towards desired product characteristics, including access, equity and affordability considerations. At present, there are no available public-interest TPPs for snake antivenoms. WHO will develop such TPPs with preferred and minimally acceptable profiles for antivenom therapeutics. An initial focus is on Sub-Saharan Africa, to be followed by equivalent TPPs for South Asia and for both small molecule and engineered antibody therapeutics. The resultant WHO TPPs will be widely shared through diverse communication channels and publications, and listed in the WHO Health Product Profile Directory. TPPs will assist manufacturers, regulators, clinicians and researchers with product standardization and guide more targeted research and development of antivenoms.