Integrating Engineering, Manufacturing, and Regulatory Considerations in the Development of Novel Antivenoms

Andreas Hougaard Laustsen*, Netty Dorrestijn

*Corresponding author for this work

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Snakebite envenoming is a neglected tropical disease that requires immediate attention. Conventional plasma-derived snakebite antivenoms have existed for more than 120 years and have been instrumental in saving thousands of lives. However, both a need and an opportunity exist for harnessing biotechnology and modern drug development approaches to develop novel snakebite antivenoms with better efficacy, safety, and affordability. For this to be realized, though, development approaches, clinical testing, and manufacturing must be feasible for any novel treatment modality to be brought to the clinic. Here, we present engineering, manufacturing, and regulatory considerations that need to be taken into account for any development process for a novel antivenom product, with a particular emphasis on novel antivenoms based on mixtures of monoclonal antibodies. We highlight key drug development challenges that must be addressed, and we attempt to outline some of the important shifts that may have to occur in the ways snakebite antivenoms are designed and evaluated.
Original languageEnglish
Article number309
Issue number8
Number of pages8
Publication statusPublished - 2018

Bibliographical note

This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) licens (


  • Snakebite envenoming
  • Antivenom
  • Monoclonal antibodies
  • Antivenom manufacture
  • Antivenom development
  • Next-generation antivenom
  • Antivenom regulation


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