title: Concise Review: Manufacturing of Pancreatic Endoderm Cells for Clinical Trials in Type 1 Diabetes.
abstract: The cellular component of ViaCyte's VC-01 combination product for type 1 diabetes, pancreatic endoderm cells (PEC-01) derived from CyT49 human embryonic stem cells, matures after transplantation and functions to regulate blood glucose in rodent models. The aims in manufacturing PEC-01 at scale are to generate a consistent and robust transplantable population that functions reliably and safely in vivo. ViaCyte has integrated multiple bioprocessing strategies to enable a tightly controlled PEC-01 manufacturing process for clinical entry.
authors.affiliation: ViaCyte, Inc., San Diego, California, USA tschulz@viacyte.com.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Schulz
mesh_terms: D001786:Blood Glucose / Q000378:metabolism; D002454:Cell Differentiation / Q000235:genetics; D002986:Clinical Trials as Topic; D003922:Diabetes Mellitus, Type 1 / Q000473:pathology / Q000628:therapy*; D053595:Embryonic Stem Cells / Q000637:transplantation*; D006801:Humans; D050417:Insulin-Secreting Cells / Q000166:cytology* / Q000378:metabolism; D010179:Pancreas / Q000378:metabolism / Q000473:pathology*
chemical_list: D001786:Blood Glucose
keywords: Cell differentiation; Embryonic stem cells; Endoderm; Pancreas