Strategies for Achieving Measurement Assurance for Cell Therapy Products.

ABSTRACT:

Unlabelled

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.

Significance

Application of these strategies to cell measurements will help to establish qualified assays for cell characterization, which may help stream

SUBMITTER: Simon CG 

PROVIDER: S-EPMC4878336 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature