ProKidney to establish cell therapy manufacturing site in North Carolina

The cell therapy biotech ProKidney is putting down manufacturing roots near its headquarters in North Carolina’s Triad region.

ProKidney announced Tuesday that it purchased a 210,000-square-foot facility along with 22 acres of land in the city of Greensboro, NC, to build out the manufacturing apparatus for its autologous cell therapy platform called REACT. The biotech is currently in Phase III development for the treatment of diabetic chronic kidney disease, a type of kidney disease caused by diabetes that affects one-third of adults with diabetes. The Greensboro site is close to ProKidney’s headquarters and pilot manufacturing site in Winston-Salem, NC.

ProKidney will pay $25.5 million in cash for the property and the facility, and it plans to scale up and make more investments in the facility to prepare for commercial-scale manufacturing. According to North Carolina Gov. Roy Cooper’s office, ProKidney could potentially invest up to $485 million in the site. The transaction is expected to be finalized by the end of June.

ProKidney could also receive up to $13.3 million in tax credits if the company hits certain milestones set out by the city of Greensboro, Guilford County and the North Carolina State Economic Investment Committee. These milestones include the creation of at least 330 new jobs paying around $74,000 by the end of 2028.

Tim Bertram

“With a staged investment strategy based on the clinical trial success of REACT, potential regulatory approval and ultimately commercial demand, if approved, we intend, along with our current Winston-Salem facility, to supply enough REACT to match initial commercial demand,” ProKidney CEO Tim Bertram said in a release.

ProKidney plans to submit a BLA for its REACT platform to the FDA in 2026, with a commercial launch expected the same year.

“With these timelines in mind, we are developing our infrastructure in preparation for ProKidney’s potential shift to a commercial organization,” Bertram said.

The Tar Heel State is a growing destination for pharmas and biotechs establishing their manufacturing operations, but most have been contained to the Triangle region near Raleigh. Eli Lilly, Fujifilm and Astellas have opened or announced plans to build or expand manufacturing facilities in the Triangle as of late.

ProKidney was founded in 2015. It then spent $62 million to acquire InRegen and later jumped into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya in early 2022.

manufacturing
cell therapy
biotech
fda