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As with other medicinal products, the success rate of ATMP products reaching commercialization is often lower than desired, if not worse. One critical factor for improving success is having a deep understanding of product critical quality attributes (CQAs) and critical process parameters (CPPs). Join speaker George Todorov and industry leaders in this session as we take a deep dive into the discovery and development of advanced therapy medicinal products (ATMPs), sharing experiences and insights to improve the success rate of ATMP product commercialization. We'll also delve into the specific topic of lifecycle management and comparability of AAV gene therapy, using real-world examples to illustrate best practices. Don't miss out on this valuable opportunity to enhance your understanding of ATMPs and their commercialization potential.

1015 – 1115: Improving Manufacturability ATMP Discovery to Commercial by Erich Bozenhardt, Zhimei Du, and George Todorov
1115 – 1145: Bringing Processing Home by Mao-shih Liang & John Easson

For session information, visit the ISPE Annual Meeting website.


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