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Contamination Control in Cell/Gene Therapy Facilities
On June 18, 2020, PDA Midwest is hosting a dinner meeting focusing on Contamination Control in Cell & Gene Therapy at the Watershed Kitchen & Bar in Columbus, Ohio. Enjoy the atmosphere, current topics and the opportunity to network with your peers during the welcome/registration hour starting at 5:00 pm. Private distillery tours at 6:00. Dinner will be served at 6:45 pm with the presentation following shortly thereafter.
Cell and Gene Therapy Quality and Manufacturing Insights from the CDMO Perspective
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.
|Registration||5:00pm – 6:00pm|
|Private Distillery Tour||6:00pm – 6:45pm|
|Dinner||6:45pm – 7:30pm|
|Presentation 1||7:30pm – 8:30pm|
Pricing is $40 for General Admission