ATMP Sterility Testing

Stem cell therapy is a groundbreaking field in the pharmaceutical industry, offering powerful tools for treating severe diseases such as cancer. The genetic manipulations involved in this process, however, necessitate stringent regulations to ensure sterility and safety. In 2017, the Food and Drug Administration (FDA) took significant steps towards regulating stem cell therapy, marking a pivotal moment in the industry. This blog provides a background in ATMP sterility testing and the FDA in relation to the paper linked below that outlines guidelines on good manufacturing practice specific to Advanced Therapy Medicinal Products.