GMP manufacturing overview for living products

GMP manufacturing of living products can take on multiple forms. The range of issues can be reviewed using two very different products, fecal transplantation and live virus onco-therapies. The FDA will use enforcement discretion when a licensed physician oversees all aspects of a limited and compassionate patient treatment. Beyond this single exception, all living products, obtained by donor banks or cell culture are subject to the rigors of GMP manufacturing and subject to routine inspection by various regulatory agencies. This presentation will recap the current GMP manufacturing expectations and highlight those issues that are of special interest in the development of living products.