Development of the First World Health Organization Lentiviral Vector Standard: Toward the Production Control and Standardization of Lentivirus-Based Gene Therapy Products.
Cast your vote
You can rate an item by clicking the amount of stars they wish to award to this item.
When enough users have cast their vote on this item, the average rating will also be shown.
Your vote was cast
Thank you for your feedback
Thank you for your feedback
MetadataShow full item record
AbstractGene therapy is a rapidly evolving field. So far, there have been >2,400 gene therapy products in clinical trials and four products on the market. A prerequisite for producing gene therapy products is ensuring their quality and safety. This requires appropriately controlled and standardized production and testing procedures that result in consistent safety and efficacy. Assuring the quality and safety of lentivirus-based gene therapy products in particular presents a great challenge because they are cell-based multigene products that include viral and therapeutic proteins as well as modified cells. In addition to the continuous refinement of a product, changes in production sites and manufacturing processes have become more and more common, posing challenges to developers regarding reproducibility and comparability of results. This paper discusses the concept of developing a first World Health Organization International Standard, suitable for the standardization of assays and enabling comparison of cross-trial and cross-manufacturing results for this important vector platform. The standard will be expected to optimize the development of gene therapy medicinal products, which is especially important, given the usually orphan nature of the diseases to be treated, naturally hampering reproducibility and comparability of results.
CitationDevelopment of the First World Health Organization Lentiviral Vector Standard: Toward the Production Control and Standardization of Lentivirus-Based Gene Therapy Products. 2017, 28 (4):205-214 Hum Gene Ther Methods
AffiliationTwinCore, Zentrum für experimentelle und klinische Infektionsforschung GmbH, Feodor-Lynen Str. 7, 30625 Hannover, Germany.
JournalHuman gene therapy methods
The following license files are associated with this item:
- Creative Commons
Except where otherwise noted, this item's license is described as http://creativecommons.org/licenses/by-nc-sa/4.0/
- Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice.
- Authors: Gándara C, Affleck V, Stoll EA
- Issue date: 2018 Feb
- Phase I/II Manufacture of Lentiviral Vectors Under GMP in an Academic Setting.
- Authors: Dasgupta A, Tinch S, Szczur K, Ernst R, Shryock N, Kaylor C, Lewis K, Day E, Truong T, Swaney W
- Issue date: 2020
- Replication-competent lentivirus analysis of clinical grade vector products.
- Authors: Cornetta K, Yao J, Jasti A, Koop S, Douglas M, Hsu D, Couture LA, Hawkins T, Duffy L
- Issue date: 2011 Mar
- A Guide to Approaching Regulatory Considerations for Lentiviral-Mediated Gene Therapies.
- Authors: White M, Whittaker R, Gándara C, Stoll EA
- Issue date: 2017 Aug
- Ethical considerations in the use of lentiviral vectors for genetic transfer.
- Authors: Roy I
- Issue date: 2001 Nov