Modernizing pharma manufacturing with AMT designation

What is the AMT Designation Program?

The FDA's AMT Designation Program is designed to encourage the adoption of innovative manufacturing technologies that promise substantial improvements to the drug development process within the pharmaceutical industry. These methods might include entirely new technologies or the novel application of established techniques.

The program's three primary objectives include the following:

• Improving drug quality.
• Accelerating development timelines.
• Ensuring supply chain reliability.

Advanced manufacturing technologies are particularly valuable for drugs that are life-supporting, life-sustaining or essential to healthcare delivery. "These technologies can directly improve product quality (e.g., through better manufacturing controls and fewer human interventions)," the guidance document noted.

The program is also geared toward addressing shortages of critical medicines -- a persistent issue in the pharmaceutical industry.

Criteria for eligibility

The eligibility criteria highlight the importance of novelty, requiring technologies to showcase either groundbreaking innovations or transformative applications of existing methods.

"Any technology can be considered for AMT designation if it meets the eligibility criteria outlined in section 506L(b) of the FD&C Act, the requestor provides sufficient data and information to demonstrate eligibility, and the technology is mature enough to consistently and reliably manufacture a product for its intended use," according to the FDA guidance.

Eligible technologies must demonstrate the potential to enhance manufacturing processes and ensure consistent product quality.

Once a technology receives an AMT designation, it benefits from prioritized interaction with FDA experts. This support facilitates early identification and resolution of potential regulatory challenges, streamlining the path from development to commercialization.

The guidance states that the "FDA will facilitate development and expedite assessment of an application, including supplements, for drugs manufactured using a designated AMT."

The application process is collaborative. Companies must submit detailed documentation highlighting the technology's benefits, such as its impact on drug quality, development timelines and supply chain reliability. A cross-disciplinary team of FDA experts reviews submissions and provides timely feedback, promoting transparency and engagement.

To qualify for AMT designation, a technology must meet specific benchmarks. "A method of manufacturing or combination of methods is eligible for AMT designation if it incorporates a novel technology or applies an established technique in a novel way," the guidance explains.

The technology should deliver measurable improvements, such as significantly reducing drug development timelines or addressing critical supply challenges. For instance, advanced manufacturing methods could alleviate drug shortages or enhance scalability for high-demand therapies.

Additionally, the technology must demonstrate sufficient maturity to produce consistent and reliable results. Developers of less mature technologies are encouraged to explore other FDA initiatives, such as the Center for Drug Evaluation and Research (CDER) Emerging Technology Program or the Center for Biologics Evaluation and Research (CBER) Advanced Technologies Team.

Navigating the process

The AMT Designation Program provides a structured and transparent pathway for companies to introduce and implement novel manufacturing technologies.

Submission and evaluation

Companies submit a comprehensive application that outlines the technology's novelty and impact. Submissions must include robust data demonstrating the method's ability to enhance manufacturing processes and product quality.

As per the guidance, "FDA intends to assess the proposed changes, including supporting data, to confirm that the designated AMT continues to meet criteria for designation." A dedicated FDA team reviews these applications and provides a determination within 180 days.

Lifecycle management

After designation, technology holders must communicate any changes that might affect the technology's eligibility or context of use. This ensures that the innovation remains aligned with regulatory expectations and continues to deliver its promised benefits. Over time, technologies can "graduate" from the program as they become more widely adopted, allowing the FDA to refocus resources on newer innovations.

Industry impact

The AMT Designation Program is designed to tackle key challenges in pharmaceutical manufacturing, focusing on the following areas:

• Streamlining regulatory processes. Early and ongoing collaboration with FDA experts ensures a smoother regulatory journey for designated technologies. This includes addressing technical challenges and aligning the technology with existing regulatory frameworks. As the guidance notes, "FDA expects to prioritize applicant interactions involving the use of a designated AMT in drug development or commercial manufacturing."
• Accelerating drug development. By integrating advanced manufacturing methods early in the development process, companies can significantly reduce the time required to bring therapies to market. This is particularly crucial for life-saving treatments and therapies addressing unmet medical needs.
• Ensuring supply chain resilience. The COVID-19 pandemic underscored the fragility of global supply chains. Advanced manufacturing technologies can mitigate disruptions by enabling more localized and flexible production models, ensuring a steady supply of critical medications.
• Enhancing product quality. Automated and data-driven processes reduce the likelihood of human error, resulting in more consistent and higher-quality products. This not only benefits patients but also enhances industry compliance with regulatory standards.

Complementary FDA initiatives

While the AMT Designation Program is tailored for ready-to-implement technologies, it complements other FDA initiatives developed to foster innovation:

• CDER's Emerging Technology Program. This initiative focuses on earlier-stage innovations, providing a platform for companies to explore new ideas before they reach maturity.
• CBER's Advanced Technologies Team. This coalition promotes the development of novel biologics manufacturing methods.
• The Platform Technology Designation Program. This program targets well-established methods, emphasizing their reproducibility and scalability.

These programs collectively create a robust ecosystem for innovation, addressing the full spectrum of development, from ideation to commercialization.

The future of advanced manufacturing

The AMT Designation Program marks a significant milestone in the FDA's mission to modernize pharmaceutical manufacturing. By promoting the use of advanced technologies, the initiative seeks to build a more agile, efficient and resilient industry.

The guidance highlights that once the FDA has accumulated substantial experience with a designated AMT and the technology has been implemented in multiple approved applications, it might transition the technology to the standard quality assessment process, signaling its broader acceptance.

For pharmaceutical companies, this program presents a valuable opportunity to collaborate with the FDA, streamline operations and strengthen their competitive edge in a rapidly evolving market. With applications open until Oct. 1, 2032, stakeholders are encouraged to act promptly to explore its potential.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.