National Institutes of Health–sponsored Clinical Islet Transplantation Consortium phase 3 trial: manufacture of a complex cellular product at eight processing facilities
C Ricordi, JS Goldstein, AN Balamurugan, GL Szot… - Diabetes, 2016 - Am Diabetes Assoc
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 …
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 …
[PDF][PDF] NIH-sponsored clinical islet transplantation consortium phase 3 trial: manufacture of a complex cellular product at eight processing facilities
C Ricordi, JS Goldstein, AN Balamurugan, GL Szot… - Diabetes, 2016 - researchgate.net
Transplantation (CIT) Consortium jointly developed and implemented a harmonized process
for manufacture of the 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 (MPBR), standard operating procedures including
acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI
product specifications, certificate of analysis (CoA) and test methods. The process was …
for manufacture of the 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 (MPBR), standard operating procedures including
acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI
product specifications, certificate of analysis (CoA) and test methods. The process was …