1. The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process
- Author
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Rob Lambkin-Williams, Nicolas Noulin, Alex Mann, D. Fullen, Andrew Catchpole, and Anthony Gilbert
- Subjects
0301 basic medicine ,Computer science ,Process (engineering) ,viruses ,Best practice ,lcsh:Medicine ,Viral challenge ,Respiratory syncytial virus ,Antibodies, Viral ,Human rhinovirus ,Risk Assessment ,General Biochemistry, Genetics and Molecular Biology ,03 medical and health sciences ,0302 clinical medicine ,Clinical trials ,Drug Discovery ,Human viral challenge model ,Humans ,030212 general & internal medicine ,lcsh:Science (General) ,lcsh:QH301-705.5 ,International standard ,GMP ,lcsh:R ,Good manufacturing process ,HVC ,General Medicine ,Adventitious agent testing ,Influenza ,Asthma ,Research Note ,030104 developmental biology ,lcsh:Biology (General) ,Drug development ,Risk analysis (engineering) ,Viruses ,Experimental challenge ,lcsh:Q1-390 - Abstract
Objective This manuscript aims to provide an overview of the unique considerations and best practice principles associated with the manufacture of human viral challenge agents. Results Considerations are discussed on the entire process from strain and viral source selection through manufacturing, safety and efficacy testing. The human viral challenge (HVC) model is an important tool to help accelerate the drug development process but producing viruses suitable for use in the model presents a unique set of challenges. There are many case by case decisions and risk assessments to consider and no clear international standard to produce viruses for this purpose. The authors present challenge virus manufacturing considerations from the current literature, regulatory guidance and their own direct experience in producing challenge viruses. The use of these viral stocks in clinical studies, as published in peer-reviewed journals, is also briefly described. Electronic supplementary material The online version of this article (10.1186/s13104-018-3636-7) contains supplementary material, which is available to authorized users.
- Published
- 2018