- Kincell Bio is expanding its Research Triangle Park (RTP), North Carolina facility by adding two ISO 7 cleanroom suites and supporting infrastructure.
- The expansion is expected to be fully operational by the end of the third quarter of 2026 and will support late-stage clinical and commercial cell therapy manufacturing.
Kincell Bio has announced a strategic investment to expand its Research Triangle Park (RTP), North Carolina facility, increasing its capacity to support autologous and allogeneic cell therapy programs. The CDMO stated that the expansion is designed to support clients progressing from late-stage clinical development through commercialization and post-approval manufacturing.
The RTP site currently serves as the company’s center for pivotal supply and commercial manufacturing, complementing its early-phase facility in Gainesville, Florida. The expansion will add two ISO 7 cleanroom suites to the existing four, increasing capacity for commercial-scale manufacturing of cell therapies.
The build-out also includes additional infrastructure such as a new quality control laboratory, MSAT/ASAT laboratory for process validation and technology transfer, and a microbiology laboratory to support sterility testing. Additional investments include an expanded GMP warehouse and workspace capacity for more than 100 employees.
The company is also investing in digital systems, including enhancements to its Veeva quality management system and enterprise resource planning (ERP) platform. These upgrades are intended to support operational scalability and improve quality and program management as more therapies advance toward commercialization.
“A number of our clients are preparing for commercialization, and these investments will ensure that our infrastructure is ready to support them at every stage of that journey.”
Larry Pitcher, Chief Executive Officer of Kincell Bio
