Month: May 2025

Targeted Cell Therapy

How Potency Assay Strategy Can Accelerate Cell Therapy Development

In cell therapy development, a product’s potency – its biological activity – is a make-or-break attribute. Regulatory agencies consider potency a critical quality attribute (CQA) that must be measured for each lot to ensure the therapy will have its intended clinical effect​. In FDA’s terms, potency is “the specific ability or capacity of the product […]

Written by on May 1, 2025