Bioassay Bridging or Comparability: Regulatory Considerations and Case Study

The development and validation of bioassays are essential for ensuring the safety, efficacy, and quality of biopharmaceutical products. Bioassay bridging, which involves transitioning from one bioassay to another while maintaining consistent product quality, presents unique regulatory and scientific challenges. This presentation discusses key regulatory considerations in bioassay bridging, emphasizing the importance of establishing comparability, accuracy, and reproducibility between the legacy and new assay methods. A case study will also be presented to illustrate practical aspects of bioassay bridging, including establishing potency method equivalency, designing the study, conducting bridging and equivalence testing, and managing change control and documentation.