Strategies for Achieving Measurement Assurance for Cell Therapy Products

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. 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. Significance The regenerative medicine industry has identified the lack of reliable methods for measuring critical cell attributes as possibly the single greatest challenge facing the field. There are many strategies for achieving measurement assurance, or confidence in cell assays, which can streamline regulatory approval and enable more efficient development of cell-based therapies.
Source: Stem Cells Translational Medicine - Category: Stem Cells Authors: Tags: Standards, Policies, Protocols, and Regulations for Cell-Based Therapies Meeting Reports Source Type: research