Potency Assays 101: How To Develop A CMC Relative Potency Assay

Developing a potency assay for biologics often presents the biggest challenge within release and stability testing. While regulations mandate reflecting the drug's mechanism of action (MOA), simplicity remains crucial. Each step introduces potential variability, impacting assay performance. Complex molecules with diverse MOAs might require multiple assays to comprehensively assess potency and faithfully mimic their biological behavior in the lab. This eBook dissects the potency assay development process into its key steps, offering a clearer understanding of the journey.