The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process.

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

SUBMITTER: Catchpole AP 

PROVIDER: S-EPMC6114718 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature