Correction to: Considerations in Developing Reporter Gene Bioassays for Biologics

The establishment of a robust and reproducible functional bioassay that reliably measures drug potency while ascertaining its mode of action is essential in biologic drug development. Here we describe a simple bioluminescent reporter gene bioassay for assessing biologics targeting immune checkpoints without the complexity and variability of more traditional assay systems. This chapter provides an overview of key considerations in reporter gene bioassay design and optimization, as well as development of thaw-and-use cells as an assay reagent for biologic QC lot release.