AUTOLOGOUS CELL THERAPY
Cell therapy is the prevention or treatment of human disease by the administration of a persons own cells that have been selected, multiplied and manipulated outside the body.
Engineering damaged tissues and organs by stimulating the body’s own repair mechanisms to functionally heal previously irreparable tissues or organs.
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.
We recognize that the development of robust and reproducible production methods becomes increasingly important as the product advances through clinical trials towards successful commercialization. Process development strategies are implemented to gain efficiency while maintaining optimal safety and quality profiles.
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 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.