Lot Release Potency Testing

Potency measurement is a requirement for regulatory submission and lot release testing. The assays used for GMP lot release must comply with current GMP regulations, while those used for non-clinical lot release do not require GMP compliance. Typically, the data collected from non-clinical studies can be used for planning clinical trials in humans.

Our QC Testing Services Team performs testing on:

• Non-clinical release samples
• GMP lot release samples

Our potency assay platform includes both Ligand Binding (LBA) and Cell-Based Assays, applicable to all phases of drug development. We discuss the different assay development and testing strategies to ensure that your bioassay meets the criteria requested by regulatory authorities. If an assay is in place, we start by evaluating the historical performance data.

Our team of scientific experts ensures that the chosen bioassay is robust and fit for its purpose. Moreover, we ensure that the selected bioassay is reliable and mimics your drug's intended mechanism of action (MoA).

For the GMP lot release testing, we will work with your team to establish a release specification that defines the range of acceptable potency values.