title: Strategies for Achieving Measurement Assurance for Cell Therapy Products.
abstract: The cell therapy industry has identified the inability to reliably characterize cells as possibly its greatest challenge and has called for standards and reference materials to provide assurance for measurements of cell properties. The challenges in characterization of cell therapy products can be largely addressed with systematic approaches for assessing sources of uncertainty and improving confidence in key measurements. This article presents the many strategies that can be used to ensure measurement confidence and discusses them in terms of how they can be applied to characterization of cell therapy products.
  
  
  CONCLUSIONS
  Application of these strategies to cell measurements will help to establish qualified assays for cell characterization, which may help streamline regulatory approval and enable more efficient development of cell therapy products.
authors.forename: Carl G
authors.initials: CG
authors.lastname: Simon
authors.forename: Sheng
authors.initials: S
authors.lastname: Lin-Gibson
authors.forename: John T
authors.initials: JT
authors.lastname: Elliott
authors.forename: Sumona
authors.initials: S
authors.lastname: Sarkar
authors.forename: Anne L
authors.initials: AL
authors.lastname: Plant
mesh_terms: D064987:Cell- and Tissue-Based Therapy / Q000379:methods* / Q000592:standards; D006801:Humans; D057026:Induced Pluripotent Stem Cells / Q000166:cytology* / Q000637:transplantation; D059630:Mesenchymal Stem Cells / Q000166:cytology*; D013601:T-Lymphocytes / Q000166:cytology*