Journal article
National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities
Diabetes (New York, N.Y.), Vol.65(11), pp.3418-3428
11/01/2016
DOI: 10.2337/db16-0234
PMCID: PMC5079635
PMID: 27465220
Abstract
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.
Details
- Title: Subtitle
- National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities
- Creators
- Camillo Ricordi - University of MiamiJulia S. Goldstein - National Institute of Allergy and Infectious DiseasesA. N. Balamurugan - University of MinnesotaGregory L. Szot - University of California, San FranciscoTatsuya Kin - University of AlbertaChengyang Liu - University of PennsylvaniaChristine W. Czarniecki - National Institute of Allergy and Infectious DiseasesBarbara Barbaro - University of Illinois Hospital & Health Sciences SystemNancy D. Bridges - National Institute of Allergy and Infectious DiseasesJose Cano - Emory UniversityWilliam R. Clarke - University of IowaThomas L. Eggerman - National Institute of Diabetes and Digestive and Kidney DiseasesLawrence G. Hunsicker - University of IowaDixon B. Kaufman - Northwestern UniversityAisha Khan - University of MiamiDavid-Erick Lafontant - University of IowaElina Linetsky - University of MiamiXunrong Luo - Northwestern UniversityJames F. Markmann - Massachusetts General HospitalAli Naji - University of PennsylvaniaOne Korsgren - Uppsala UniversityJose Oberholzer - University of Illinois Hospital & Health Sciences SystemNicole A. Turgeon - Emory UniversityDaniel Brandhorst - Uppsala UniversityAndrew S. Friberg - Uppsala UniversityJi Lei - Massachusetts General HospitalLing-jia Wang - Northwestern UniversityJoshua J. Wilhelm - University of MinnesotaJamie Willits - University of IowaXiaomin Zhang - Northwestern UniversityBernhard J. Hering - University of MinnesotaAndrew M. Posselt - University of California, San FranciscoPeter G. Stock - University of California, San FranciscoA. M. James Shapiro - University of Alberta
- Resource Type
- Journal article
- Publication Details
- Diabetes (New York, N.Y.), Vol.65(11), pp.3418-3428
- DOI
- 10.2337/db16-0234
- PMID
- 27465220
- PMCID
- PMC5079635
- NLM abbreviation
- Diabetes
- ISSN
- 0012-1797
- eISSN
- 1939-327X
- Publisher
- Amer Diabetes Assoc
- Number of pages
- 11
- Grant note
- U01-DK-070430 / University of Pennsylvania (Philadelphia, PA) 5M01-RR-000400; UL1-TR-000114 / University of Minnesota; University of Minnesota System U01-DK-070431 / University of Iowa (Iowa City, IA) UL1-TR-000454 / General Clinical Research Center Awards and Clinical and Translational Science Awards: Emory University UL1-TR-000050 / University of Illinois at Chicago U01-AI-065192 / Uppsala University (Uppsala, Sweden) UL1-TR-000004 / University of California, San Francisco; University of California System M01-RR-00040; UL1-TR-000003 / University of Pennsylvania U01-DK-085531 / University of California, San Francisco (San Francisco, CA); University of California System U01-DK-070460 / University of Miami (Miami, FL)
- Language
- English
- Date published
- 11/01/2016
- Academic Unit
- Biostatistics; Nephrology; Internal Medicine
- Record Identifier
- 9984772260402771
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