FDA’s AMT Designation Battles Commercial Failures in Cell and Gene Therapy

November 25, 2025 — The challenge of manufacturing cell and gene therapies (CGT) reliably and profitably at scale is threatening the commercial success of the sector, but the U.S. Food and Drug Administration’s (FDA) Advanced Manufacturing Technologies (AMT) designation is emerging as a potential solution. Experts say the program, finalized late last year, is vital for companies needing to overhaul inefficient production methods after securing regulatory approval.

Approval vs. Commercial Viability

The history of the CGT sector demonstrates that winning FDA approval is often just the first step. Companies frequently encounter a “scaling crisis” where initial, often manual, production methods cannot keep pace with commercial demand.

• Inefficiency Breakdown: Anna McMahon, Director of Regulatory Affairs at Cellares, explained that relying on manual handling and paper records causes production to “buckle” under pressure. This leads to supply delays, missed treatment slots, and growing patient waitlists.

• Historical Failures: The inability to scale profitably has led to significant commercial failures, including the 2014 bankruptcy of Dendreon and the recent sale of bluebird bio (now Genetix Biotherapeutics) after it struggled with production for approved therapies like Zynteglo and Skysona.

Regulatory expert Don Fink of Dark Horse Consulting noted that many companies enter the market with “hands-on, less automated” processes, resulting in high costs and constrained output.

AMT Designation Streamlines Post-Approval Changes

The FDA’s AMT designation aims to accelerate the adoption of modernized, automated manufacturing technologies. It is particularly valuable for companies making post-approval pivots—switching to a new process once the drug is already on the market.

• Comparability: By having an approved product, companies can conduct comparability tests to prove the new manufacturing process yields an identical drug, which is key to winning FDA approval for the change.

• Regulatory Support: McMahon highlighted that the AMT status provides a formal “venue to align the plan, acceptance criteria and documentation expectations upfront” with the FDA, preventing costly and time-consuming disruptions.

As the number of approved CGTs continues to grow—with 15 additional therapies potentially submitted to the FDA in 2025—the AMT pathway is becoming indispensable for translating scientific breakthroughs into sustainable commercial realities.