Immunogenicity testing helps establish the safety of experimental therapies by ensuring drugs don’t trigger a potentially dangerous immune response. While regulators had long relied on a fixed, three-tier immunogenicity testing model, the industry is now shifting to a flexible, risk-based approach that continues to meet regulatory requirements and ensure patient safety. We spoke to Katie Sime, principal research scientist at Charles River Laboratories, about when reduced-tier approaches make sense, what regulators want to see; and why adaptive strategies can particularly benefit resource-constrained biotechs by balancing scientific rigor, patient safety, and budget constraints.