The Sanford Strategy: How the FDA and Kyowa Kirin Are Remaking Drug Manufacturing

PRINCETON, NJ – June 30, 2026

In a move signaling a significant shift in U.S. regulatory policy, the Food and Drug Administration (FDA) has selected Japanese pharmaceutical giant Kyowa Kirin for its new PreCheck Pilot Program. The collaboration centers on the company’s state-of-the-art biologics facility, currently rising from the ground in Sanford, North Carolina. This partnership is more than just a procedural tweak; it represents a fundamental rethinking of how critical medicines are brought to market, an operational innovation designed to de-risk development, accelerate timelines, and bolster a fragile domestic supply chain.

At stake is the production of complex biologics, particularly next-generation antibodies for rare and orphan diseases—medicines whose specialized, low-volume manufacturing processes are notoriously vulnerable to regulatory bottlenecks. By embedding itself in the facility’s development from the ground up, the FDA is testing a new model of proactive collaboration that could become the blueprint for future biopharmaceutical manufacturing in the United States.

A New Regulatory Blueprint

The FDA PreCheck Pilot Program is a quiet revolution in regulatory science. Traditionally, the agency’s deep engagement with a new manufacturing plant would occur late in the game, during the formal review of a drug application. This sequential process, while thorough, is fraught with risk. A facility built at the cost of hundreds of millions of dollars could face crippling delays or require expensive retrofits if compliance issues are discovered during a final-stage inspection.

The PreCheck program flips the script. It replaces the traditional, sequential review with a proactive, two-phase collaborative framework. In Phase 1, the Facility Readiness Phase, Kyowa Kirin will use a special Drug Master File to gain real-time technical feedback from the FDA on everything from equipment qualification to its Pharmaceutical Quality System design. This early engagement is designed to eliminate the risk of post-construction compliance gaps.

As the facility nears completion, the partnership will move to Phase 2, the Application Submission Phase. Here, structured pre-submission engagements will streamline the review of the complex Chemistry, Manufacturing, and Controls (CMC) data, which forms the backbone of any drug application. According to regulatory experts, this front-loading of the review process has the potential to significantly shorten the timeline between a drug’s application and its ultimate approval, getting vital medicines to patients months or even years faster.

This initiative builds on the philosophy of other successful FDA programs like Breakthrough Therapy and Fast Track designations, which accelerate product development. The PreCheck program extends this logic to the factory itself, recognizing that the facility is as critical to patient access as the molecule it produces.

Kyowa Kirin’s Strategic U.S. Foothold

For Kyowa Kirin, a 70-year-old global specialty pharmaceutical company, the selection is a landmark event. The Sanford facility, which broke ground in late 2024, is the company's first manufacturing footprint in the United States and a core component of its global strategy to dominate the rare disease market.

“Being selected for the FDA PreCheck Pilot Program is a transformative milestone for Kyowa Kirin as a global organization,” said Toshiyuki Kurata, the company’s Chief Supply Chain Officer. “With this program we have the opportunity to build our quality and compliance framework from the ground up in close collaboration with the FDA — establishing a new standard for how we approach manufacturing.”

The strategic rationale is clear. Establishing a domestic manufacturing base reduces reliance on international shipping and insulates the company’s most important market from geopolitical shocks and supply chain disruptions. For a company focused on highly specialized, life-altering therapies for rare diseases, ensuring an uninterrupted supply is paramount.

Steve Schaefer, President of Kyowa Kirin North America, emphasized the patient-centric goals. “One of our primary goals for participating in the FDA PreCheck Pilot Program is the acceleration of the review and approval process to ensure a resilient product supply to patients suffering from rare diseases and other unmet medical needs,” he stated. This early collaboration provides a significant competitive advantage, reducing regulatory risk and providing a faster, more predictable path to market than competitors following the traditional, longer route.

From Pandemic Lessons to Supply Chain Resilience

The PreCheck program is not happening in a vacuum. It is a direct response to the hard lessons learned during the COVID-19 pandemic, which laid bare the vulnerabilities of a highly globalized, “just-in-time” pharmaceutical supply chain. Government agencies from the Department of Health and Human Services (HHS) to the White House have since issued reports and strategies calling for the onshoring of critical manufacturing to enhance national medicine security.

Complex biologics for rare diseases represent a key point of fragility. Their manufacturing is often concentrated in a handful of specialized sites globally. A disruption at a single facility, whether due to a natural disaster, quality issue, or geopolitical tension, can jeopardize the supply for an entire patient population with no alternative.

By incentivizing and accelerating the construction of facilities like Kyowa Kirin’s Sanford plant, the FDA is actively helping to diversify and strengthen the domestic production base. This move contributes directly to national health security by creating a more resilient supply of medicines that are difficult to produce and essential for vulnerable patients. Market analysts note that this alignment of corporate strategy with national policy creates a powerful tailwind for companies like Kyowa Kirin that are investing in U.S.-based advanced manufacturing.

North Carolina’s Biomanufacturing Ascendancy

On the ground in North Carolina, the impact is more immediate. Kyowa Kirin’s $200 million investment is set to create over 100 high-skilled jobs in Lee County, with roles in biomanufacturing, engineering, and quality control that command competitive salaries. This direct investment will have a significant multiplier effect, boosting local suppliers and service industries.

The project solidifies Sanford’s position within North Carolina's burgeoning “BioPharma Crescent.” The city is already home to a major Pfizer gene therapy facility, creating a powerful cluster of talent, suppliers, and institutional knowledge. Kyowa Kirin's arrival, supported by state incentives like a Job Development Investment Grant (JDIG), further cements the region's status as a critical hub for the future of American biomanufacturing.

This investment is a testament to North Carolina’s long-term strategy of cultivating its life sciences sector through partnerships between government, industry, and its world-class university and community college systems. As the nation works to rebuild its pharmaceutical manufacturing capabilities, projects like the one in Sanford demonstrate how strategic public-private collaboration can yield benefits for local economies, national security, and, most importantly, the patients waiting for life-changing medicines.