Engaging the FDA on Innovation in Biomanufacturing

Innovation drives improvements in developing and manufacturing biotherapeutics. Nonetheless, improvements must still meet regulatory requirements. At the FDA, the Center for Drug Evaluation and Research’s Emerging Technology Program (CDER-ETP) helps biotechnology and pharmaceutical companies innovate and still negotiate any regulatory steps as easily as possible.

“The Emerging Technology Program employs a combination of early engagement, face-to-face meetings, FDA site visits, integrated quality assessments, and pre-approval inspections,” said Sau (Larry) Lee, director of the emerging technology team (ETT). “The same ETT representatives that engage with the company will likely be involved in the entire process.”

Companies can even get involved before starting regulatory steps. “The company, if accepted into the Emerging Technology Program, can get early feedback regarding its emerging technology from the FDA, even before the company identifies a drug or product candidate associated with the technology,” Lee explained.

When asked what technologies companies inquire about, Lee said, “Our experience related to emerging technologies for biological molecules includes: controlled ice nucleation for lyophilization processes; comprehensive product testing using a single multi-attribute assay; continuous manufacturing for a downstream process; end-to-end integrated bioprocess; and small manufacturing platforms for continuous bioprocesses, such as pharmacy on demand.”

Across this wide range of methods, the CDER-ETP eases the regulatory process in many ways for a company focused on applying innovation in biomanufacturing. “A company gets a forum for early dialogue with FDA to support innovation; identification of potential roadblocks relating to existing guidance, standards, policy, or practice; and consistency and continuity in assessment and inspection,” Lee said.

Certainly, many companies could make use of those benefits. Although obstacles and opportunities create a perilous balance—even in the best cases—companies look for ways to reduce the risk, and the CDER-ETP could be one. Taking innovation to the edge and then marketing it requires teamwork—teamwork that begins as soon as possible and persists.

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