FDA PreCheck pilot: Fujifilm Holly Springs and Cellares say they are among seven

Primary source Fujifilm Biotechnologies: FUJIFILM Biotechnologies Selected in FDA PreCheck Pilot Program to Advance U.S. Drug Manufacturing 8 Jul 2026

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Two manufacturers in our scope have said they were selected for the FDA’s PreCheck pilot: Cellares on 30 June 2026 and Fujifilm Biotechnologies, for its Holly Springs, North Carolina site, on 8 July 2026. Both releases say the pilot has seven participants. These are summer announcements, covered here as context for anyone planning a new U.S. facility. The FDA’s own announcement sits on fda.gov, which we could not open, so the program description below comes from the FDA notice in the Federal Register and from the two companies.

What PreCheck is

The FDA notice of 8 August 2025 describes PreCheck, then a proposal, as a response to Executive Order 14293, in two phases:

• Facility Readiness Phase. Pre-operational review, with FDA feedback at facility design, pre-construction, construction, equipment installation and qualification, and pre-production. Facility information is submitted in a Type V Drug Master File that can be referenced in later applications.
• Application Submission Phase. Pre-application meetings, CMC feedback, and accelerated quality assessments for applications from new U.S. facilities.

The notice adds that PreCheck support will be commensurate with the regulatory resources available. Cellares says the FDA received over 80 requests to join and selected seven companies.

The two participants

• Fujifilm, Holly Springs. A USD 3.2 billion site that opened with 8 x 20,000 L mammalian cell culture bioreactors. An expansion under way adds another 8 x 20,000 L, and Fujifilm says it will bring its opening forward by 6 months, targeting late FY2027. A drug product line is due in early 2027. The site makes monoclonal antibodies for customers including argenx, Johnson & Johnson and Regeneron.
• Cellares. The company describes itself as the only cell therapy platform among the seven, and says PreCheck lets it validate its Cell Shuttle manufacturing and Cell Q quality control systems against FDA standards before product applications are filed. The release does not name which facility is enrolled; its first commercial-scale site is in Bridgewater, New Jersey.

What it means for a plant

As described in the FDA notice, PreCheck moves facility review earlier in the project, from pre-approval inspection back to design and qualification. For a project team, that means the site documentation (site layout, quality system elements) has to be mature enough to share with the FDA while the building is still going up. Neither release reports an outcome yet, and the FDA notice ties the level of support to its resources.