A paper by Netty Dorrestijn (managing director UCAB) and Andreas Laustsen (Department of Biotechnology and Biomedicine at Technical University of Denmark) on snake antivenoms was published in Toxins. It highlights both the need and the opportunity for using biotechnology and modern drug development approaches to develop novel snakebite antivenoms with better efficacy, safety, and affordability compared to the conventional plasma-derived snakebite antivenoms. Engeneering, manufacturing, and regulatory considerations regarding the development process of, especially novel antivenoms based on mixtures of monoclonal antibodies are discussed. Finally, the paper provides insights in key drug development challenges for these monoclonal antibodies and suggests important shifts in designing and evaluation of snakebite antivenoms .
The paper, entitled “Integrating Engineering, Manufacturing, and Regulatory Considerations in the Development of Novel Antivenoms” is available here.
1. Laustsen, A.H.; Dorrestijn, N. Integrating Engineering, Manufacturing, and Regulatory Considerations in the Development of Novel Antivenoms. Toxins 2018, 10, 309.