The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Friday issued a guidance to assist sponsors of cell and gene therapies (CGTs) in determining whether certain types of manufacturing changes to their products would necessitate the filing of a new investigational new drug application (IND) or biologics license application (BLA).
The guidance also addresses the information that should be included in comparability studies demonstrating that manufacturing changes do not adversely affect the quality of the post-change products.
Current FDA guidance addresses comparability studies and managing manufacturing changes for biological products, but not cell and gene therapy products. Excluded from the scope of the guidance are vaccines for infectious disease indications, bacteriophage products, live biotherapeutic products, fecal microbiota for transplantation (FMT) products and allergenic products…
