ProKidney building NC plant to support auto cell therapy

The facility in Greensboro, North Carolina will support future commercial production of ProKidney’s Phase III autologous cell therapy for chronic kidney disease.

Up to $485 million will be put into the 210,000 square-foot manufacturing facility in anticipation of the potential approval of ProKidney’s lead candidate REACT (REnal Autologous Cell Therapy).

REACT is a cell therapy that aims to treat chronic kidney disease (CKD) by using a patient’s own kidney cells. The therapy, which has US Regenerative Medicine Advanced Therapy (RMAT) fast-track designation, is in Phase III clinical trials, with data evaluation anticipated for late 2025 and potential US approval in 2026, according to ProKidney regulatory filings.

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The facility in Greensboro, Guildford County will, according to the firm, feature multiple breakthroughs in the manufacturing automation, supply chain, and medical delivery of cellular therapy products.

According to CEO Tim Bertram, North Carolina was selected due to the “depth and breadth of biotechnology talent, the advantage of locating the plant near our headquarters and pilot manufacturing plant in Winston-Salem, NC, and the state’s interest in continuing to grow its biotechnology industry.”

The decision also has the support of the North Carolina Department of Commerce and ProKidney will be subject to up to $5,132,700 in reimbursements spread over 12 years from the Job Development Investment Grant (JDIG).

“North Carolina is known as a biotech and life science leader, and Greensboro and the Piedmont Triad region are an important part of that story,” said NC Representative John Faircloth. “Our community applauds ProKidney’s continued success and we stand ready to support them during this next phase of their company’s growth.”

The list of biomanufacturing projects and investments in North Carolina is endless. Some examples include Amgen’s $550 million plant in Holly Springs, the nearby 160,000 L Fujifilm Diosynth Biotechnologies plant under construction at a cost of ¥200 billion ($1.4 billion), and the $1 billion project underway by Eli Lilly in Concord.