Factors affecting the Turnaround Time for Manufacturing, Testing and Release of Cellular Therapy Products prepared at Multiple Sites in support of Multicenter Cardiovascular Regenerative Medicine Protocols – a Cardiovascular Cell Therapy Research Network (CCTRN) Study

BACKGROUND: Cellular therapy studies are often conducted at multiple clinical sites in order to accrue larger patient numbers. In many cases this necessitates use of localized Good Manufacturing Practices (GMP) facilities to supply the cells. To assure consistent quality, oversight by a quality assu...

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Main Authors: Richman, Sara, Gee, Adrian P., McKenna, David, Traverse, Jay, Henry, Timothy, Fisk, Diann, Pepine, Carl, Bloom, Jeannette, Willerson, James, Prater, Karen, Zhao, David, Koç, Jane Reese, Anwaruddian, Saif, Taylor, Doris, Cogle, Christopher, Moyé, Lemuel, Simari, Robert, Skarlatos, Sonia
Format: Artigo
Language:Inglês
Published: 2012
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Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC3355200/
https://ncbi.nlm.nih.gov/pubmed/22320233
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/j.1537-2995.2011.03543.x
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