Current Good Manufacturing Practice
Current Good Manufacturing Practice (cGMP) is the United States Food and Drug Administration’s (FDA) monitoring program to ensure quality pharmaceuticals manufacturing. cGMP regulations establish minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. These regulations are disseminated a series of guidelines dictated by the FDA which companies must adapt and adhere to.
Our 18,000 square foot cGMP facility is located in San Diego at the heart of the biotech sector. It has over 4,000 square feet of clean room space rated up to Class 3 (ISO 5). Our facility, along with our various protocols and procedures have been designed to strictly adhere to or exceed cGMP guidelines.
We have established this space to produce induced pluripotent stem cells (iPSCs) under cGMP conditions to serve the pharmaceutical and academic research communities by providing a solution for high quality iPSCs. In addition to this we are also offering stem cell generation and banking services.