FDA’s Advanced Manufacturing Technology Program: Accelerating the Drive to integrated Automated Manufacturing

April 15, 2024 12:45 pm || David Shenberger || Categorized in:

The US Food and Drug Administration (FDA) has launched a new Advanced Manufacturing Technologies (AMT) Designation program aimed at accelerating the implementation of technologies that drive speed to patient and enhanced sustainability. For innovative companies, this provides an exciting opportunity to improve processes and drive sustainability. This initiative is part of the FDA’s ongoing efforts to support the adoption of innovative manufacturing technologies that can improve drug quality, address shortages, and increase manufacturing capacity and flexibility. In this blog, we will explore the key aspects of the AMT program and its potential impact on the pharmaceutical industry.

Key Features of the AMT Program

  1. Draft Guidance: The FDA has issued draft guidance detailing the AMT program, which is open for comments until February 12, 2024.
  1. Eligibility: The program is open to drug sponsors, contract manufacturers, technology developers, and others.
  1. Benefits: The AMT designation can help expedite and accelerate scale manufacturing, offer new solutions to address drug shortages, and increase supply chain resilience.
  1. Builds on Existing Initiatives: The AMT program is complementary to the FDA’s Emerging Technology Program (ETP), established in 2014 to help pharmaceutical companies resolve novel technical and regulatory challenges.

The Impact of the AMT Program

The AMT program is expected to have a significant impact on the pharmaceutical industry by:

  • Encouraging the development and adoption of advanced manufacturing technologies.
  • Addressing drug shortages and improving drug quality.
  • Increasing manufacturing capacity and flexibility.
  • Enhancing supply chain resilience.

How to Engage with the AMT Program

According to the draft guidance, manufacturers planning for the adoption of a designated technology should engage early with the FDA. Specifically with CDER’s Emerging Technology Program (ETT) or CBER’s Advanced Technology Program (CATT) as they are testing the technology during the development process.

However, in contrast with these programs, the AMT designation is for mature technologies that have a strong basis in engineering and science with available performance data. In addition, AMT is specifically for manufacturing and is limited to a method or combination of methods for manufacturing a drug while ETT and CATT are applicable across a wide range of discovery and development activities.

One way to think of AMT is the new manufacturing approach must either use a novel technology or implement an established technology in a novel way.

The FDA’s Advanced Manufacturing Technologies Designation program represents a significant step forward in promoting the adoption of innovative manufacturing technologies in the pharmaceutical industry. By participating in the program, drug sponsors can gain a competitive edge, improve drug quality, contribute to addressing drug shortages, and increase supply chain resilience.

The draft guidance is available at Advanced Manufacturing Technologies Designation Program (fda.gov)

Tags: , , , ,