ProKidney has developed an investigational cell-based product called REACT (Renal Autologous Cell Therapy), designed to improve 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 selected renal cells (SRC). 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.
Diabetic Kidney Disease is the most common cause of Chronic Kidney Disease in the United States, with no therapies that have the ability to stop progression or improve renal function. ProKidney is currently conducting multiple clinical trials for REACT in patients with Chronic Kidney Disease. Previous trials demonstrated that REACT may be well tolerated by patients with moderate to severe Diabetic Kidney Disease, and based on early results, is now under investigation in Phase 3 studies to determine whether it can stop or delay progression of Diabetic Kidney Disease.
Our dedicated team of cell therapy scientists has developed 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 safety and quality profiles.
We take a range of approaches to tackle the challenges with the development of our investigational cell therapies. The clinical and future 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 promising cell therapy candidates using GMP compliant manufacturing methodologies.
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 experience gained over a decade provides us with deep process development and analytical knowledge, and has enabled the implementation of robust manufacturing solutions that we utilize in developing our products.