Open AccessTissue Dissociation Enzymes for Isolating Human Islets for Transplantation: Factors to Consider in Setting Enzyme Acceptance Criteria
Author(s) -
Robert C. McCarthy,
Andrew G. Breite,
Michael L. Green,
Francis E. Dwulet
Publication year - 2011
Publication title -
transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.45
H-Index - 204
eISSN - 1534-6080
pISSN - 0041-1337
DOI - 10.1097/tp.0b013e3181ffff7d
Subject(s) - islet , transplantation , food and drug administration , enzyme , diabetes mellitus , medicine , biology , biochemistry , risk analysis (engineering) , endocrinology
Tissue dissociation enzymes are critical reagents that affect the yield and quality of human pancreatic islets required for islet transplantation. The United States Food and Drug Administration's oversight of this procedure recommends laboratories to set acceptance criteria for enzymes used in the manufacture of islet products for transplantation. Currently, many laboratories base this selection on personal experience because biochemical analysis is not predictive of success of the islet isolation procedure. This review identifies the challenges of correlating results from enzyme biochemical analysis to their effectiveness in human islet isolation and suggests a path forward to address these challenges to improve control of the islet manufacturing process.