Potency Assays in Tolerance Therapies: Driving Reproducibility, Standardization & Predictive Value
- Implementing standardized methodologies to create consistent and reliable potency assays for tolerance therapies, ensuring product quality and regulatory compliance
- Establishing clear acceptance criteria and validation protocols for potency assays, moving beyond theoretical frameworks to provide actionable guidelines for clinical and commercial applications
- Utilizing mechanistic insights from potency assays to predict therapeutic outcomes, guiding dose optimization and patient stratification for improved clinical efficacy