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Abstract
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.
Highlights
Each year, snakebite envenoming exacts a death toll of more than 100,000 victims and maims more than 400,000 others [1]
Since Césaire Auguste Phisalix, Gabriel Bertrand, and Albert Calmette simultaneously described the use of heterologous antivenom serotherapy in 1894 [4], limited developments have been introduced to the field of snakebite envenoming therapy, where animal-plasma-derived immunoglobulins remain the mainstay of treatment [5]
As a final word on the development and manufacturing processes for novel antivenoms, it is relevant to consider molecules for which quality control (QC) is easy to perform and validate, and where manufacturing processes are easy to transfer to low-cost manufacturing sites
Summary
Snakebite envenoming exacts a death toll of more than 100,000 victims and maims more than 400,000 others [1]. Toxins 2018, 10, x FOR PEER REVIEW development risks, which in turn will improve the translation of novel experimental antivenoms into considerations on how to reduce both development and manufacturing costs. When the lab work for the scientist often ends, namely with publication of a leadwith identification dwarffor any cost incurred in preclinical research and development, and a failure in clinical trials will a certain target, the critical development process starts. It is essential to late evaluate scientific advances effects in the light the risks associated with safety, regulatory approval, evaluate new scientific advances in the light of the risks associated with safety, regulatory approval, stage development, and manufacture.
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