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ProKidney Announces Manufacturing Efficiency Initiatives and Supply Chain
Streamlining Expected to Reduce REACT™ Manufacturing Costs
Company anticipates that costs for REACT™ could decrease by up to 50% compared
to the cost of manufacturing for its Phase 2 clinical trial
WINSTON-SALEM, N.C., June 15, 2022 — ProKidney LP (“ProKidney”), a leading clinical-stage cellular therapeutics company focused on therapies for chronic kidney disease (“CKD”), today announced an update on manufacturing efficiency and supply chain streamlining initiatives, which could reduce manufacturing costs.
ProKidney’s current costs of manufacturing REACT™ for use in its ongoing Phase 2 Clinical Trial RMCL-002 is approximately $100,000 per patient. ProKidney anticipates that these costs will be lower for its Phase 3 trials and will continue to decrease by potentially up to 50% compared to the cost of manufacturing REACT™ for its Phase 2 RMCL-002 study as it manufactures REACT™ at commercial scale. ProKidney plans to achieve these cost reductions through the implementation of automation, bioprocess developments, formulation improvements, and streamlining of the supply chain.
ProKidney expects to utilize automation in all aspects of manufacturing ranging from tissue processing, cell expansion and renal cell selection to formulation and filling of the final product. It will also extend automation to other manufacturing activities including warehouse operations and supply chain.
In addition, ProKidney intends to improve bioprocess development to further reduce manufacturing costs of the commercial REACT™ product, assuming receipt of necessary regulatory approvals. Culture media currently represents the highest cost in REACT™ processing, and ProKidney is exploring reduced culture media usage via bioprocess and automation improvements.
Further, ProKidney’s final commercial REACT™ product is planned to be a cryopreserved formulation, which is projected to reduce manufacturing costs compared to its fresh REACT™ formulation. ProKidney expects to leverage bulk purchasing to actively negotiate pricing of materials to further drive cost reductions.
“To augment the renal repair process over a patient’s lifetime requires effective, efficient, and highly scalable manufacturing capabilities. We believe that these initiatives, which are expected to reduce cost of manufacturing by as much as 50% compared to our Phase 2 study, signify an important step forward toward optimization of our manufacturing process,” said Dr. Deepak Jain, Chief Operating Officer of ProKidney. “Our manufacturing process has well established modules and uses GMP-grade materials commonly recognized by regulatory agencies around the world. Over the past 10+ years, we have worked to develop a reproducible, consistent, and dependable process that is readily scalable for commercial expansion. With the implementation of automation, bioprocess developments, formulation improvements, and streamlining of the supply chain, we believe we can reduce the cost of manufacturing.”