GDF2026 - Recent Trends in Pharmaceutical Freeze-Drying and Control Strategies
Center for Drug Evaluation and Research (CDER) presentation · July 30, 2026
FDA CDER presenter Steve Ryu reviewed lyophilization (freeze-drying) in drug manufacturing, common deficiencies the agency sees, recommended control strategies including PAT tools, and inspection findings; he urged manufacturers to ensure facilities and processes are inspection-ready before submitting applications.
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