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

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 biotechn...

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Bibliographic Details
Published inToxins Vol. 10; no. 8; p. 309
Main Authors Laustsen, Andreas Hougaard, Dorrestijn, Netty
Format Journal Article
LanguageEnglish
Published Switzerland MDPI AG 31.07.2018
MDPI
Subjects
Antivenom
antivenom development
antivenom manufacture
antivenom regulation
Biotechnology
Costs
Drug development
Good Manufacturing Practice
Immunoglobulins
Manufacturing
Medical research
Monoclonal antibodies
next-generation antivenom
Product development
Production capacity
R&D
Regulatory approval
Research & development
Respiratory syncytial virus
snakebite envenoming
Snakes
Trends
Tropical diseases
Vaccines
Venom
Switzerland
next-generation antivenom
snakebite envenoming
antivenom
antivenom development
antivenom regulation
antivenom manufacture
monoclonal antibodies
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Summary: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.
ISSN:2072-6651
2072-6651
DOI:10.3390/toxins10080309