Kriya Therapeutics Selected for FDA PreCheck Pilot Program to Advance U.S. Gene Therapy Manufacturing
Kriya Therapeutics, Inc., a biotechnology company focused on developing durable gene therapies for chronic diseases, has announced that it has been selected by the U.S. Food and Drug Administration (FDA) to participate in the agency’s FDA PreCheck Pilot Program. The selection represents a significant milestone for the company and recognizes its ongoing investment in advanced manufacturing capabilities designed to support the future commercialization of gene therapies in the United States.
The FDA chose Kriya through a competitive evaluation process that assessed participating companies on the strength of their manufacturing capabilities, facility development plans, and commitment to adopting modern manufacturing technologies. Through the program, Kriya will work closely with the FDA as it develops its new commercial manufacturing facility in Research Triangle Park, North Carolina, which is expected to produce the company’s pipeline of adeno-associated virus (AAV)-based gene therapies currently being evaluated in clinical studies for chronic diseases.
The selection places Kriya among a limited group of companies collaborating directly with the FDA to strengthen domestic pharmaceutical manufacturing while accelerating the development and availability of innovative medicines.
Strengthening Manufacturing as a Core Strategic Capability
Kriya views manufacturing as a central component of its long-term business strategy rather than simply a supporting function for product development. Since its founding in 2019, the company has invested heavily in building an integrated manufacturing platform capable of supporting every stage of gene therapy development—from early research through commercial production.
Commenting on the announcement, Shankar Ramaswamy, M.D., Chief Executive Officer and Co-Founder of Kriya Therapeutics, said the company’s inclusion in the FDA PreCheck Pilot Program validates years of strategic investment in developing internal manufacturing expertise.
He explained that Kriya was established with the goal of creating transformative, durable medicines capable of addressing chronic diseases affecting millions of people. Equally important, however, was the vision of building the manufacturing infrastructure needed to produce those therapies efficiently, consistently, and at commercial scale.
Dr. Ramaswamy added that participation in the FDA initiative provides an opportunity for ongoing collaboration with regulators as Kriya advances its gene therapy portfolio toward future commercialization.
Purpose of the FDA PreCheck Pilot Program
The FDA PreCheck Pilot Program is part of the agency’s broader effort to modernize pharmaceutical manufacturing and strengthen the resilience of the United States drug supply chain.
Rather than waiting until a manufacturing facility is completed before beginning formal regulatory interactions, the program allows participating companies to engage with the FDA much earlier during facility development.
This collaborative approach enables regulators to provide continuous feedback throughout several stages of the project, including:
- Facility planning and design
- Construction
- Equipment installation
- Operational readiness
- Manufacturing process implementation
- Inspection preparation
The goal is to reduce uncertainty during facility development while streamlining regulatory review and inspection processes once production begins.
By fostering earlier communication between manufacturers and regulators, the FDA hopes to improve regulatory predictability, accelerate commercialization timelines, and encourage greater investment in domestic pharmaceutical manufacturing.
Expanding U.S. Manufacturing Capacity
The PreCheck initiative also aligns with broader national efforts to increase pharmaceutical production within the United States.
In recent years, supply chain disruptions have highlighted the importance of strengthening domestic manufacturing capacity for critical medicines and advanced therapies.
The FDA has emphasized the need for facilities that utilize state-of-the-art manufacturing technologies capable of delivering high-quality products while improving production efficiency.
Participating facilities are expected to incorporate modern approaches such as:
- Digital manufacturing systems
- Advanced automation
- Data-driven process monitoring
- Quality-by-design principles
- Continuous process optimization
These technologies can improve consistency, reduce manufacturing variability, and enhance overall product quality.
Kriya’s new manufacturing facility has been designed with these objectives in mind.
Research Triangle Park Facility to Support Clinical and Commercial Production
The company’s commercial manufacturing facility is being established in Research Triangle Park (RTP), North Carolina, one of the United States’ leading biotechnology and life sciences hubs.
The facility will manufacture Kriya’s portfolio of AAV-based gene therapy products, which are currently progressing through clinical development for various chronic diseases.
Unlike conventional pharmaceutical manufacturing plants that may focus exclusively on commercial production, Kriya’s facility is intended to support both:
- Clinical manufacturing for ongoing and future clinical trials
- Commercial-scale production following potential regulatory approvals
This dual-purpose design provides flexibility as programs advance through different stages of development while allowing manufacturing knowledge generated during clinical production to transition smoothly into commercial operations.
Building an Integrated Gene Therapy Manufacturing Platform
Gene therapy manufacturing is widely recognized as one of the most technically demanding areas within the biopharmaceutical industry.
Producing viral vector-based medicines requires highly specialized expertise across numerous scientific and engineering disciplines.
To address these challenges, Kriya has developed an integrated manufacturing platform encompassing multiple critical capabilities, including:
- Proprietary AAV vector engineering
- Process development
- Analytical testing
- Good Manufacturing Practice (GMP) production
- Quality management systems
By maintaining these capabilities internally, the company aims to improve control over manufacturing quality while reducing reliance on external contract manufacturers.
This vertically integrated approach also supports faster process optimization as development programs evolve.
Leveraging Automation and Digital Technologies
A distinguishing feature of Kriya’s manufacturing strategy is its emphasis on digital innovation.
The company has incorporated automation and advanced digital technologies throughout its manufacturing platform to improve operational performance.
Automation can reduce manual variability during production while enabling more consistent manufacturing outcomes.
Digital process monitoring also allows manufacturers to collect extensive operational data, supporting real-time quality assessment and continuous process improvement.
These technologies are expected to enhance:
- Manufacturing efficiency
- Product consistency
- Production scalability
- Operational reliability
- Regulatory compliance
Such capabilities become increasingly important as gene therapies move toward larger-scale commercial production.
HOPSON™: A Data-Driven Manufacturing Platform
Supporting Kriya’s physical manufacturing infrastructure is HOPSON™, the company’s proprietary structured data platform.
HOPSON serves as a centralized digital repository for manufacturing knowledge generated across Kriya’s operations.
Since the company’s founding in 2019, the platform has accumulated more than 80 million individual data points derived from internal manufacturing runs.
This extensive dataset provides valuable insights into process performance, product quality, equipment behavior, and operational consistency.
Using advanced analytics, the platform enables Kriya to identify trends, optimize manufacturing parameters, and continually improve production processes.
The integration of large-scale manufacturing data into routine operations represents an increasingly important element of modern biopharmaceutical production, particularly for complex biologic products such as gene therapies.
Supporting the Future Commercialization of Durable Medicines
Kriya’s primary focus is the development of durable medicines for chronic diseases.
Unlike traditional therapies that often require lifelong treatment, durable gene therapies are designed to provide long-lasting therapeutic effects following limited administration.
The company’s AAV-based platform seeks to deliver genetic material capable of producing sustained clinical benefits over extended periods.
As these therapies advance through clinical development, manufacturing becomes a critical determinant of successful commercialization.
Reliable production processes are essential not only for regulatory approval but also for ensuring that sufficient quantities of high-quality medicines can be supplied to patients.
Kriya’s investment in manufacturing infrastructure reflects its preparation for that future demand.
Collaboration with Regulators
Participation in the FDA PreCheck Pilot Program underscores Kriya’s commitment to maintaining an open and collaborative relationship with regulators throughout facility development.
Rather than viewing regulatory oversight as a final hurdle before commercialization, the company intends to engage continuously with the FDA as manufacturing capabilities mature.
This proactive approach may help identify potential issues earlier, facilitate more efficient inspections, and support smoother regulatory review once commercial applications are submitted.
For innovative therapies such as gene therapies, early regulatory engagement can be particularly valuable because manufacturing processes are often highly specialized and technically complex.
Kriya Therapeutics’ selection for the FDA PreCheck Pilot Program represents an important step in the company’s efforts to build a fully integrated manufacturing platform capable of supporting the next generation of gene therapies for chronic diseases. The initiative recognizes Kriya’s investments in advanced manufacturing technologies, digital infrastructure, automation, and domestic production capacity, while also providing an opportunity for closer collaboration with the FDA throughout the development of its new commercial manufacturing facility.
As Kriya continues advancing its pipeline of AAV-based gene therapies through clinical development, participation in the PreCheck Pilot Program is expected to strengthen its manufacturing readiness and position the company for future commercialization. By combining scientific innovation with modern manufacturing capabilities and proactive regulatory engagement, Kriya aims to improve the efficiency, scalability, and accessibility of durable medicines that could ultimately benefit patients living with chronic diseases.
About Kriya Therapeutics®
Our mission is to revolutionize medicine, with the ultimate goal of eliminating human suffering and enabling people to live without the burden of disease. Kriya is a clinical-stage biopharmaceutical company developing gene therapies to address chronic diseases affecting millions of people around the world. Our pipeline includes potentially transformational medicines in multiple therapeutic areas—including in ophthalmology, metabolic disease and neurology—built on our fully-integrated proprietary manufacturing and engineering platform.
