The Big4Bio Podcast The Big4Bio Podcast shares podcasts that give ins Author: Big4Bio The Big4Bio Podcast shares podcasts that give insight and information about/from biotech and life science leaders and organizations within the Big4Bio regions. Check out our Playlists to hear podcasts by region. Be a guest on this podcast Language: en Genres: Science Contact email: Get it Feed URL: Get it iTunes ID: Get it Get all podcast data

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Every Moment Matters: A Case for Adaptive Immunogenicity Testing
Wednesday, 18 February, 2026

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.

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