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FDA presenter urges manufacturers to prove lyophilization control before filing
Summary
Commander Steve Ryu of FDA CDER told an industry audience that manufacturers must identify drying endpoints, adopt appropriate control strategies such as PAT tools, and ensure facilities meet cGMP standards before submitting drug applications.
Commander Steve Ryu, of the U.S. Public Health Service in the Office of Pharmaceutical Manufacturing Assessment at CDER, told attendees that regulators expect firms to reduce uncertainty in lyophilization and be ready for inspection at the time of application. "You absolutely must identify the endpoint of drying," Ryu said, adding that endpoint determination is not optional.
Ryu urged adopting appropriate measurement technologies and risk-based approaches, citing ICH Q9 principles. "We are encouraging the adoption of process analytical technology or PAT tools to help with this," he said. He warned manufacturers: "Don't submit an application thinking you will fix things later," and emphasized facilities should be fully cGMP-compliant before filing. The presentation concluded with a handover to the next speaker, Dr. Aldrich.
