Unveiling the Research & Mechanisms of Action for Probiotics, Ensuring Infant Formula Safety
- Strain characterization: Comprehensive genomic and phenotypic analyses to confirm the identity, stability, and safety of the strain
- Toxicity studies and animal models: predictive tools for evaluating strain safety prior to human studies. What is needed for a probiotic strain?
- Clinical studies, is growth evaluation during intervention enough? While appropriate weight and length gain confirm that the strain does not negatively impact infant development, comprehensive safety validation also requires monitoring other outcomes as gastrointestinal tolerance, infection incidence, and any adverse events
- Experience with regulatory authorities across major regions, including the FDA, China, Europe, and Australia