Evidence map›Paper›PMID 30065185›Full record

ArticleToxins2018

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

Andreas Hougaard Laustsen, Netty Dorrestijn

Abstract read
In one paragraph

Article in Toxins, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
  6. Towards better antivenoms: navigating the road to new types of snakebite envenoming therapies.The journal of venomous animals and toxins including tropical diseases · 2023
    Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Cost of Manufacturing for Recombinant Snakebite Antivenoms.Frontiers in bioengineering and biotechnology · 2020
    Article
  16. Review
  17. Perspective on the Therapeutics of Anti-Snake Venom.Molecules (Basel, Switzerland) · 2019
    Review
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Andreas Hougaard LaustsenDepartment of Biotechnology and Biomedicine, Technical University of Denmark, DK-2800 Kongens Lyngby, Denmark. ahola@bio.dtu.dk.ORCID 0000-0001-6918-5574
Netty DorrestijnUtrecht Center for Affordable Biotherapeutics, Department of Pharmaceutical Sciences, Utrecht University, 3584 CG Utrecht, The Netherlands. j.dorrestijn@uu.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AnimalsAntiveninsCommerceDrug IndustryEngineeringHumansLegislation, DrugSnake BitesAntiveninsantivenomantivenom developmentantivenom manufactureantivenom regulationmonoclonal antibodiesnext-generation antivenomsnakebite envenoming

Identifiers

PMID30065185
PMCPMC6115708

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.