tetano
Editor, Senior Moderator
BMC Res Notes. 2018 Aug 29;11(1):620. doi: 10.1186/s13104-018-3636-7.
[h=1]The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process.[/h] Catchpole AP[SUP]1[/SUP], Fullen DJ[SUP]2[/SUP], Noulin N[SUP]2[/SUP], Mann A[SUP]2[/SUP], Gilbert AS[SUP]2[/SUP], Lambkin-Williams R[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVE:[/h] This manuscript aims to provide an overview of the unique considerations and best practice principles associated with the manufacture of human viral challenge agents.
[h=4]RESULTS:[/h] 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.
[h=4]KEYWORDS:[/h] Adventitious agent testing; Asthma; Clinical trials; Experimental challenge; GMP; Good manufacturing process; HVC; Human rhinovirus; Human viral challenge model; Influenza; Respiratory syncytial virus; Viral challenge
PMID: 30157933 DOI: 10.1186/s13104-018-3636-7
Free full text
[h=1]The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process.[/h] Catchpole AP[SUP]1[/SUP], Fullen DJ[SUP]2[/SUP], Noulin N[SUP]2[/SUP], Mann A[SUP]2[/SUP], Gilbert AS[SUP]2[/SUP], Lambkin-Williams R[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVE:[/h] This manuscript aims to provide an overview of the unique considerations and best practice principles associated with the manufacture of human viral challenge agents.
[h=4]RESULTS:[/h] 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.
[h=4]KEYWORDS:[/h] Adventitious agent testing; Asthma; Clinical trials; Experimental challenge; GMP; Good manufacturing process; HVC; Human rhinovirus; Human viral challenge model; Influenza; Respiratory syncytial virus; Viral challenge
PMID: 30157933 DOI: 10.1186/s13104-018-3636-7
Free full text