Designing Potency Assays That Matter: Bridging In Vivo, In Vitro, and Emerging Modalities
Vaccine developers face an increasingly complex landscape—new modalities, rising regulatory expectations, and the global shift toward modern potency testing. Ensuring a vaccine's potency isn't just a regulatory hurdle; it's the foundation of product quality, clinical success, and market readiness.
This whitepaper reveals what today's biotech teams need to know to avoid delays, reduce risk, and maintain confidence from early development through commercial release.
You'll gain a clear understanding of:
- Why potency is a strategic quality attribute and not just a compliance requirement
- The biggest challenges in potency assay design, including immune system complexity, biological variability, and bridging in vivo and in vitro systems
- How multivalent and next generation vaccine platforms intensify testing demands
- The realities of transitioning toward New Approach Methodologies (NAMs) while maintaining global regulatory compliance
- The path to robust assay validation, including ICH expectations and GMP readiness
- Why delays occur—and how the right partner prevents them
With more than 20 years of vaccine potency experience across in vivo, in vitro, and next generation analytical platforms, Charles River Laboratories provides the scientific rigor, regulatory insight, and validated systems to keep development on pace and products moving forward.