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Toxins 2018, 10(8), 309; https://doi.org/10.3390/toxins10080309

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

1
Department of Biotechnology and Biomedicine, Technical University of Denmark, DK-2800 Kongens Lyngby, Denmark
2
Utrecht Center for Affordable Biotherapeutics, Department of Pharmaceutical Sciences, Utrecht University, 3584 CG Utrecht, The Netherlands
*
Author to whom correspondence should be addressed.
Received: 7 July 2018 / Revised: 23 July 2018 / Accepted: 27 July 2018 / Published: 31 July 2018
(This article belongs to the Special Issue Snakebite – From Science to Society. Selected papers)
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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. View Full-Text
Keywords: snakebite envenoming; antivenom; monoclonal antibodies; antivenom manufacture; antivenom development; next-generation antivenom; antivenom regulation snakebite envenoming; antivenom; monoclonal antibodies; antivenom manufacture; antivenom development; next-generation antivenom; antivenom regulation
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).
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Laustsen, A.H.; Dorrestijn, N. Integrating Engineering, Manufacturing, and Regulatory Considerations in the Development of Novel Antivenoms. Toxins 2018, 10, 309.

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