Potency assay to predict the anti-inflammatory capacity of a cell therapy product for macrophage-driven diseases: overcoming the challenges of assay development and validation.

ABSTRACT:

Background

Given the high level of product complexity and limited regulatory guidance, designing and implementing appropriate potency assays is often the most challenging part of establishing a quality control testing matrix for a cell-based medicinal product. Among the most elusive tasks are the selection of suitable read-out parameters, the development of assay designs that most closely model the pathophysiological conditions, and the validation of the methods. Here we describe these challenges and how they were addressed in developing an assay that measures the anti-inflammatory potency of mesenchymal stromal cells (MSCs) in an M1 macrophage-dominated inflammatory environment.

Methods

An in vitro inflammation model was established by coculturing skin-derived ABCB5^+</

SUBMITTER: Sadeghi S 

PROVIDER: S-EPMC11065629 | biostudies-literature | 2024 May

REPOSITORIES: biostudies-literature