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AMT Designation

Synecta Receives FDA Advanced Manufacturing Technology Designation

The FDA’s AMT designation recognizes manufacturing innovations that use novel approaches to improve the reliability, efficiency, and resilience of producing medicines. The program highlights technologies with the potential to make the supply of essential and life-saving therapies more secure and sustainable.
  • Regulatory confidence – FDA recognition that the Synecta platform meets high standards for consistency, scalability, and quality in immune activation.
  • Streamlined adoption – Early FDA engagement helps simplify integration of Synecta CDNPs into cell-therapy manufacturing workflows.
  • Reliable supply – AMT-designated technologies are recognized for strengthening the availability of critical materials that support life-saving therapies.
Amt designation fda sign

The FDA’s AMT program allows cell-therapy developers to engage early with the agency to address regulatory and technical considerations for innovative technologies.

For further details about the FDA’s Advanced Manufacturing Technologies Designation Program, see FDA AMT Guidance.

Read the press release.

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