From The Stage

Applying Cell-Based Assays, Part 2: Potency Testing for Lot Release Under GMP

Dr. Jeff Patrick
Posted by Dr. Jeff Patrick / / Cell-Based Assays

In our blog discussing the use of cellular assays for neutralizing antibody (NAb) detection, we touched on the value that bioassays offer through their ability to closely mimic the effects that a biotherapeutic drug product will have on the body without the use of animals in the study. This is what makes cell-based potency assays the choice for measuring and validating the therapeutic activity of a drug product within prescribed ranges of safety, purity, and strength (potency), which is a requirement for regulatory submission and both clinical and commercial lot…