[Image courtesy of Kincell Bio]
The contract development and manufacturing organization (CDMO) supports autologous and allogenic cell therapy programs. It expects the new expansion to support clients as they advance from late-stage clinical CMC development through commercialization and post-approval life cycle management.
Kincell says this facility serves as its center of excellence for pivotal supply, commercialization and commercial manufacturing. It complements the company’s early-phase-focused facility in Gainesville, Florida. Currently, the Research Triangle Park site houses four ISO 7 cleanroom suites. The company expects the expansion to add two more suites, meaningfully increasing its capacity to support cell therapy programs at commercial scale.
According to Kincell, the new build-out includes a comprehensive suite of supporting infrastructure. It features additional QC laboratory space to support expanded quality control testing and a purpose-built MSAT/ASAT lab.
Additionally, the site expansion includes its microbiology laboratory for rapid sterility testing and expanded GMP warehouse space. Overall the expansion also includes workspaces for more than 100 team members, supporting the growing organization.
The physical build-out complements investments in digital infrastructure by Kincell as well. The company hopes to support commercial-stage operations and invest in its Veeva quality management system. Additionally, it plans to invest in its enterprise resource planning (ERP) system.
Kincell expects to have the expanded facility operational by the end of the third quarter of 2026.
“This expansion reflects our commitment to supporting our clients’ commercial success and our confidence in the trajectory of the overall cell therapy industry,” said Larry Pitcher, CEO of Kincell Bio. “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.”
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