Cell and gene therapy manufacturers often face challenges when their chosen production processes, initially sufficient for early-stage trials, prove inadequate for commercial scale. Experts have traditionally advised companies to select a manufacturing platform during preclinical development and maintain it through clinical trials and market launch. However, this approach is not always feasible if scalability issues emerge after trials begin.
Don Fink, a regulatory expert at Dark Horse Consulting, told BioSpace that adopting new technologies before entering clinical trials is the simplest path. “By using a technology from the start of development, companies can build chemistry, manufacturing and control strategies around it from day one,” he said. Anna McMahon, director of regulatory affairs at Cellares, agreed with this view, stating that the optimal time to choose a process is before filing an Investigational New Drug (IND) application.
Switching manufacturing platforms mid-development presents unique regulatory hurdles. Fink explained that sponsors must demonstrate comparability between products made with old and new platforms. He noted that doing so without an approved drug as a baseline complicates matters further. Delaying such changes increases both time and costs, which are critical factors for success.
Recent developments may alter these risk calculations. The U.S. Food and Drug Administration (FDA) introduced its Advanced Manufacturing Technology (AMT) designation program in January 2025 to support technologies that significantly improve pharmaceutical manufacturing processes. This program offers designated technology users more opportunities to engage with the FDA during both early drug development and subsequent application assessments.
McMahon’s company received an AMT designation in April 2025 and has since engaged in discussions with the FDA under this framework. She believes the AMT designation “fundamentally changes the risk equation for cell therapy developers” by providing “a clear, repeatable path to engage FDA on manufacturing early.” According to McMahon, regulators now recognize the complexity of switching platforms and allow “staged, evidence-led transitions” rather than treating such switches as all-or-nothing events.
The AMT framework enables sponsors to validate comparability while ongoing trials continue by running side-by-side lots using agreed-upon readouts. Bridging strategies discussed with regulators help maintain dosing schedules during transitions. These interactions also allow sponsors to align on acceptance criteria before producing clinical material and plan future phases with confidence regarding identity controls and data expectations.
“This keeps trials on schedule and sets up a process that can be repeated across sites after approval,” McMahon said.
While only a few companies like Cellares and Oribiotech have received AMT designations due to the program’s recent launch, experts are watching closely to see how these regulatory changes will impact development pathways for cell and gene therapies going forward.
For now, the AMT program provides an option for sponsors concerned about launching products with costly or unscalable processes—a challenge many approved cell and gene therapies have faced in achieving commercial viability.
