Potency assays are essential for evaluating the biological activity of biopharmaceuticals, including cell and gene therapy products. These assays are crucial for ensuring product quality, consistency, and ultimately, clinical effectiveness.
Life cycle development of potency assays
Starting potency assay development early in the product lifecycle is crucial, since it allows time for
- evaluating multiple assays and selecting the most relevant and robust option,
- generating data on product stability, consistency, and establishing a relationship with clinical efficacy, and
- correlating surrogate assays to biological activity if direct measurement is not feasible.
Potency assays are vital for demonstrating the biological activity—and ultimately, the clinical promise—of biopharmaceuticals, including cell and gene therapies. Starting assay development early gives teams time to evaluate options, generate meaningful data, and link results to efficacy, even when direct measurement is complex.
In this technical note, we share two case studies:
- a cell-based assay measuring eGFP expression in LNPs using flow cytometry,
- and a ligand-binding assay evaluating a monoclonal antibody’s interaction with its target protein.
We also outline the key steps, timelines, and considerations for building assays that are both scientifically rigorous and regulatory-ready.