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National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities
Eight manufacturing facilities participating in the National Institutes of Health–sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 t...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Diabetes Association
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5079635/ https://www.ncbi.nlm.nih.gov/pubmed/27465220 http://dx.doi.org/10.2337/db16-0234 |
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author | Ricordi, Camillo Goldstein, Julia S. Balamurugan, A.N. Szot, Gregory L. Kin, Tatsuya Liu, Chengyang Czarniecki, Christine W. Barbaro, Barbara Bridges, Nancy D. Cano, Jose Clarke, William R. Eggerman, Thomas L. Hunsicker, Lawrence G. Kaufman, Dixon B. Khan, Aisha Lafontant, David-Erick Linetsky, Elina Luo, Xunrong Markmann, James F. Naji, Ali Korsgren, Olle Oberholzer, Jose Turgeon, Nicole A. Brandhorst, Daniel Chen, Xiaojuan Friberg, Andrew S. Lei, Ji Wang, Ling-jia Wilhelm, Joshua J. Willits, Jamie Zhang, Xiaomin Hering, Bernhard J. Posselt, Andrew M. Stock, Peter G. Shapiro, A.M. James |
author_facet | Ricordi, Camillo Goldstein, Julia S. Balamurugan, A.N. Szot, Gregory L. Kin, Tatsuya Liu, Chengyang Czarniecki, Christine W. Barbaro, Barbara Bridges, Nancy D. Cano, Jose Clarke, William R. Eggerman, Thomas L. Hunsicker, Lawrence G. Kaufman, Dixon B. Khan, Aisha Lafontant, David-Erick Linetsky, Elina Luo, Xunrong Markmann, James F. Naji, Ali Korsgren, Olle Oberholzer, Jose Turgeon, Nicole A. Brandhorst, Daniel Chen, Xiaojuan Friberg, Andrew S. Lei, Ji Wang, Ling-jia Wilhelm, Joshua J. Willits, Jamie Zhang, Xiaomin Hering, Bernhard J. Posselt, Andrew M. Stock, Peter G. Shapiro, A.M. James |
author_sort | Ricordi, Camillo |
collection | PubMed |
description | Eight manufacturing facilities participating in the National Institutes of Health–sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. |
format | Online Article Text |
id | pubmed-5079635 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | American Diabetes Association |
record_format | MEDLINE/PubMed |
spelling | pubmed-50796352017-11-01 National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities Ricordi, Camillo Goldstein, Julia S. Balamurugan, A.N. Szot, Gregory L. Kin, Tatsuya Liu, Chengyang Czarniecki, Christine W. Barbaro, Barbara Bridges, Nancy D. Cano, Jose Clarke, William R. Eggerman, Thomas L. Hunsicker, Lawrence G. Kaufman, Dixon B. Khan, Aisha Lafontant, David-Erick Linetsky, Elina Luo, Xunrong Markmann, James F. Naji, Ali Korsgren, Olle Oberholzer, Jose Turgeon, Nicole A. Brandhorst, Daniel Chen, Xiaojuan Friberg, Andrew S. Lei, Ji Wang, Ling-jia Wilhelm, Joshua J. Willits, Jamie Zhang, Xiaomin Hering, Bernhard J. Posselt, Andrew M. Stock, Peter G. Shapiro, A.M. James Diabetes Islet Studies Eight manufacturing facilities participating in the National Institutes of Health–sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. American Diabetes Association 2016-11 2016-07-27 /pmc/articles/PMC5079635/ /pubmed/27465220 http://dx.doi.org/10.2337/db16-0234 Text en © 2016 by the American Diabetes Association. http://www.diabetesjournals.org/content/licenseReaders may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license. |
spellingShingle | Islet Studies Ricordi, Camillo Goldstein, Julia S. Balamurugan, A.N. Szot, Gregory L. Kin, Tatsuya Liu, Chengyang Czarniecki, Christine W. Barbaro, Barbara Bridges, Nancy D. Cano, Jose Clarke, William R. Eggerman, Thomas L. Hunsicker, Lawrence G. Kaufman, Dixon B. Khan, Aisha Lafontant, David-Erick Linetsky, Elina Luo, Xunrong Markmann, James F. Naji, Ali Korsgren, Olle Oberholzer, Jose Turgeon, Nicole A. Brandhorst, Daniel Chen, Xiaojuan Friberg, Andrew S. Lei, Ji Wang, Ling-jia Wilhelm, Joshua J. Willits, Jamie Zhang, Xiaomin Hering, Bernhard J. Posselt, Andrew M. Stock, Peter G. Shapiro, A.M. James National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities |
title | National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities |
title_full | National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities |
title_fullStr | National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities |
title_full_unstemmed | National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities |
title_short | National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities |
title_sort | national institutes of health–sponsored clinical islet transplantation consortium phase 3 trial: manufacture of a complex cellular product at eight processing facilities |
topic | Islet Studies |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5079635/ https://www.ncbi.nlm.nih.gov/pubmed/27465220 http://dx.doi.org/10.2337/db16-0234 |
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