Presented by: Claire Briglia, Principal, Vedere Solutions, LLC.
Abstract: Advanced Therapy Medicinal Products (ATMP) are moving quickly into a commercial-stage and have many challenges around microbial contamination control and monitoring. According to the Personalized Medicine Coalition, "25 of the 59 new molecular entities FDA approved in 2018 are personalized medicines." In 2018, FDA drafted "Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)" to provide the industry with their current thinking on this unique new treatment. Patient safety needs to be considered carefully at each manufacturing step with a risk-based approach. This presentation will describe all the elements of a robust contamination control master plan for ATMP manufacturing.