ProKidney has developed a cell-based product called REACT (Renal Autologous Cell Therapy), designed to build renal function in patients with chronically diseased kidneys.
REACT is being developed to delay or prevent renal replacement therapy (dialysis or kidney transplant). ProKidney’s REACT is a percutaneous minimally invasive injectable product composed of the patient’s own regenerative renal cells (RRC). Because REACT is a personalized medicine composed of a patient’s own cells, there is no need for immunosuppressive therapy used for a patient’s lifetime for kidney transplant.
Over 500,000 patients per year suffer from diabetic kidney disease in the United States.
ProKidney is currently conducting multiple Phase 2 clinical trials for its REACT product. The ProKidney Phase 2 clinical trials are based on a successful internationally conducted Phase 1 clinical trial of the REACT product. Some of the first patients to be injected have been followed for over three years and remain dialysis-free. The trial demonstrated that REACT was well tolerated by patients with moderate to severe diabetic kidney disease.
Our Approach
Our dedicated team of cell therapy development scientists develop production methods to meet the requirements of our clinical programs. A product specific analytical testing program is designed and assays qualified to ensure product quality is prioritized. Process development strategies are implemented to gain efficiency while maintaining optimal safety and quality profiles.
Science-Driven
We take a range of approaches to tackle the challenges with the development of our cell therapies. The clinical and commercial success of our therapeutics hinges on the development of robust, reproducible and scalable processes. Prokidney’s extensive process development and analytical development capabilities generate active therapies using cGMP compliant manufacturing methodologies.
Process Development
Process development is a highly complex task, requiring custom-developed solutions for cell-based products. Successful process development can, therefore, only be achieved through the application of extensive experience and expertise in all aspects of GMP manufacturing and quality control. The collective learning gained over a decade provides us with a tremendous depth of process development and analytical knowledge, and the implementation of robust manufacturing solutions that we utilize in developing our products.