Extractables & Leachables Control Strategy

Extractables and leachables (E&L) expectations continue to evolve as regulators place greater emphasis on scientifically justified, risk-based assessments throughout the product lifecycle. Organizations developing biologics, cell and gene therapies, combination products, and products manufactured using single-use systems face growing pressure to identify, assess, and control E&L risk early to avoid delays, regulatory questions, and costly rework.

This approach combines study design, risk assessment, extractables characterization, leachables evaluation, toxicological assessment, and lifecycle change management into a cohesive strategy aligned with emerging industry expectations and USP guidance. From packaging selection and manufacturing process assessments to NDA/BLA readiness and commercial lifecycle support, a structured E&L program can strengthen regulatory narratives, improve submission readiness, and support confident decision-making.

Access the full brochure to explore phase-appropriate approaches for managing E&L risk from development through commercialization.