Document Detail


Vector production in an academic environment: a tool to assess production costs.
MedLine Citation:
PMID:  23360377     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Generating gene and cell therapy products under good manufacturing practices is a complex process. When determining the cost of these products, researchers must consider the large number of supplies used for manufacturing and the personnel and facility costs to generate vector and maintain a cleanroom facility. To facilitate cost estimates, the Indiana University Vector Production Facility teamed with the Indiana University Kelley School of Business to develop a costing tool that, in turn, provides pricing. The tool is designed in Microsoft Excel and is customizable to meet the needs of other core facilities. It is available from the National Gene Vector Biorepository. The tool allows cost determinations using three different costing methods and was developed in an effort to meet the A21 circular requirements for U.S. core facilities performing work for federally funded projects. The costing tool analysis reveals that the cost of vector production does not have a linear relationship with batch size. For example, increasing the production from 9 to18 liters of a retroviral vector product increases total costs a modest 1.2-fold rather than doubling in total cost. The analysis discussed in this article will help core facilities and investigators plan a cost-effective strategy for gene and cell therapy production.
Authors:
Aaron Boeke; Patrick Doumas; Lilith Reeves; Kyle McClurg; Daniela Bischof; Lina Sego; Alisha Auberry; Mohan Tatikonda; Kenneth Cornetta
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Human gene therapy methods     Volume:  24     ISSN:  1946-6544     ISO Abbreviation:  Hum Gene Ther Methods     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-02-27     Completed Date:  2013-08-28     Revised Date:  2014-02-10    
Medline Journal Info:
Nlm Unique ID:  101573202     Medline TA:  Hum Gene Ther Methods     Country:  United States    
Other Details:
Languages:  eng     Pagination:  49-57     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Cost-Benefit Analysis / economics*
Data Collection
Genetic Therapy / economics,  methods
Genetic Vectors / economics*,  genetics*
Retroviridae / genetics,  metabolism
Grant Support
ID/Acronym/Agency:
HHSN2680001//PHS HHS; P40 HL116242/HL/NHLBI NIH HHS; P40HL11621/HL/NHLBI NIH HHS; UL1 TR000006/TR/NCATS NIH HHS

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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