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 manufact...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2018-08-01
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| Series: | BMC Research Notes |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13104-018-3636-7 |
| _version_ | 1828426716538732544 |
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| author | Andrew P. Catchpole Daniel J. Fullen Nicolas Noulin Alex Mann Anthony S. Gilbert Rob Lambkin-Williams |
| author_facet | Andrew P. Catchpole Daniel J. Fullen Nicolas Noulin Alex Mann Anthony S. Gilbert Rob Lambkin-Williams |
| author_sort | Andrew P. Catchpole |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-10T16:50:33Z |
| format | Article |
| id | doaj.art-9c82bfaafacd44eb9a4d8141e98e8d7f |
| institution | Directory Open Access Journal |
| issn | 1756-0500 |
| language | English |
| last_indexed | 2024-12-10T16:50:33Z |
| publishDate | 2018-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Research Notes |
| spelling | doaj.art-9c82bfaafacd44eb9a4d8141e98e8d7f2022-12-22T01:40:55ZengBMCBMC Research Notes1756-05002018-08-011111610.1186/s13104-018-3636-7The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development processAndrew P. Catchpole0Daniel J. Fullen1Nicolas Noulin2Alex Mann3Anthony S. Gilbert4Rob Lambkin-Williams5hVivo Services LtdhVivo Services LtdhVivo Services LtdhVivo Services LtdhVivo Services LtdhVivo Services LtdAbstract 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.http://link.springer.com/article/10.1186/s13104-018-3636-7Human viral challenge modelHVCExperimental challengeViral challengeGood manufacturing processGMP |
| spellingShingle | Andrew P. Catchpole Daniel J. Fullen Nicolas Noulin Alex Mann Anthony S. Gilbert Rob Lambkin-Williams The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process BMC Research Notes Human viral challenge model HVC Experimental challenge Viral challenge Good manufacturing process GMP |
| title | The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process |
| title_full | The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process |
| title_fullStr | The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process |
| title_full_unstemmed | The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process |
| title_short | The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process |
| title_sort | manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process |
| topic | Human viral challenge model HVC Experimental challenge Viral challenge Good manufacturing process GMP |
| url | http://link.springer.com/article/10.1186/s13104-018-3636-7 |
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