Title |
The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process
|
---|---|
Published in |
BMC Research Notes, August 2018
|
DOI | 10.1186/s13104-018-3636-7 |
Pubmed ID | |
Authors |
Andrew P. Catchpole, Daniel J. Fullen, Nicolas Noulin, Alex Mann, Anthony S. Gilbert, Rob Lambkin-Williams |
Abstract |
This manuscript aims to provide an overview of the unique considerations and best practice principles associated with the manufacture of human viral challenge agents. 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 3 | 25% |
United States | 3 | 25% |
Canada | 2 | 17% |
Unknown | 4 | 33% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 8 | 67% |
Scientists | 3 | 25% |
Practitioners (doctors, other healthcare professionals) | 1 | 8% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 15 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 6 | 40% |
Student > Master | 2 | 13% |
Student > Bachelor | 1 | 7% |
Unknown | 6 | 40% |
Readers by discipline | Count | As % |
---|---|---|
Biochemistry, Genetics and Molecular Biology | 2 | 13% |
Immunology and Microbiology | 2 | 13% |
Nursing and Health Professions | 1 | 7% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 7% |
Social Sciences | 1 | 7% |
Other | 1 | 7% |
Unknown | 7 | 47% |