As of late 2019, there are currently over 400 Cell & Gene Therapy companies in the US, nearly 400 therapies in Clinical Trials and over 800 IND applications submitted to the FDA. As such there will be an onslaught of companies that will be transitioning from clinical stage to commercial manufacturing in the coming years. Many of these companies will move from a CRO/CMO operating model to their own newly constructed manufacturing facilities. ATMP companies must be prepared to take ownership and be fully prepared to manufacture their life-saving products as quickly as possible after their facility is complete and they are “handed the keys”.
This session, presented by Vince Cebular, Senior Vice President, Design and Janine Squire, Project Manager, CQV, will highlight the key requirements for Operational Readiness, present some common pitfalls and challenges, and provide a real-world case study.
More information and registration for INTERPHEX 2021 can be found here: https://www.interphex.com/