Potency assay development using DoE and QbD principles

Potency assays are essential for biologics' quality and patient safety. They measure a biologic's functional activity, verifying it works as intended. Lonza uses Quality by Design (QbD) principles to develop robust potency assays. QbD involves defining the Analytical Target Profile, identifying Critical Method Parameters, and establishing the Method Operable Design Region using Design of Experiments. This approach ensures assays are robust and reliable throughout their lifecycle. By utilizing QbD, researchers can efficiently optimize assay conditions and reduce variability.