FDA selects 3 NC sites for pilot program to boost US biomanufacturing

The U.S. Food and Drug Administration selected three biopharma companies with manufacturing sites in North Carolina for a pilot program to help develop new domestic biomanufacturing capabilities: FUJIFILM Biotechnologies, Holly Springs; Kriya Therapeutics Inc., Durham; and Kyowa Kirin, Sanford. They were among seven inaugural participating companies announced June 29 by the FDA.

Two of the other seven companies, Eli Lilly and Company and Regeneron, have a manufacturing presence in North Carolina but will be participating at their facilities in other states.

The state’s participating companies will focus on the following biomanufacturing areas:

• FUJIFILM Biotechnologies: Commercial-scale cell culture
• Kriya Therapeutics: Adeno-associated virus (AAV)-based gene therapy products to address chronic disease conditions
• Kyowa Kirin: Biotechnology drug substances for rare diseases

The pilot program is intended to help develop U.S. pharmaceutical manufacturing facilities by encouraging earlier FDA engagement and providing a more predictable regulatory pathway for companies that plan to manufacture drugs for the U.S. market, supporting greater access to critical medicines for Americans, the announcement said.

The FDA launched the program on Feb. 1, 2026, and received more than 80 requests to participate. The agency’s drug and biologic experts evaluated the requests on products to be manufactured, stage of facility development, anticipated timelines and manufacturing innovation before selecting seven participants, the announcement added.

In a post on LinkedIn, FUJIFILM Biotechnologies said, “We are honored to be among seven companies chosen to help expand domestic pharmaceutical capacity and strengthen supply chain resilience.”

To be eligible, companies were required to propose a new domestic manufacturing facility addressing a market supply need or an unmet medical need and commit to submitting a New Drug Application, Biologics License Application, Abbreviated New Drug Application, or a supplement relying on the new facility.

The other four participating companies and their focus areas are Amneal Pharmaceutical, Long Island, N.Y., small molecule sterile liquid products for pain management, respiratory and ophthalmic diseases; Cellares Corp., Bridgewater, N.J., cell-based gene therapy for oncology and hematology; Eli Lilly and Company, Lebanon, I.N., active pharmaceutical ingredients (Lilly has a biomanufacturing facility in Concord, N.C.); and Regeneron Pharmaceuticals Inc., Saratoga Springs, N.Y., biotechnology drug substances, sterile injectables and novel protein therapeutics (Regeneron is producing biologic medicines at FUJIFILM's Holly Springs facility).

The program operates in two phases. In Phase 1, participants receive early technical guidance from the FDA before facilities become operational, including reviews through a facility-specific Drug Master File. In Phase 2, participants engage in facility-focused pre-submission meetings intended to support expedited facility evaluation and earlier inspections during the review cycle.

The FDA said it will continue evaluating the pilot program and assess opportunities to inform future program development.