Current Good Manufacturing Practice (cGMP) is a set of FDA regulations outlining the requirements for methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The goal of these regulations is to ensure a product is safe for use. Our cell banking facilities and methods are designed to be fully compliant with cGMP regulations.
This means every aspect of the stem cell banking process is carefully controlled and fully documented, starting with sample collection and ending with storage of your cells in our continuously monitored cryopreservation units. Additionally, our facility and materials are rigorously tested for quality and sterility throughout all of our processes to ensure any cells generated meet the absolute highest clinical standards.