Concurrent Session: Operations Readiness, Tech Transfer & Risk-based Case Studies|The Biomanufacturing Industry has risen to a number of challenges in supply chain, drug shortages, and global deployment of manufacturing capabilities in connection with the new geopolitical map and current market needs. We have successfully introduced new ways of working and collaborating between industry and regulatory agencies starting with development and clinical trials and ending at the patient’s side. This session will provide examples of ways of working that have proven beneficial for these processes and highlight how we can continue to develop our ways of working and communication channels to further improve the global reach of our products to meet the patient’s needs. Operational readiness and a focus on reducing environmental impact as well as other areas of sustainability are important factors to further this area of production in a responsible way. The work we do now gives us an excellent opportunity to keep those aspects in everything from design for new as well as retrofitted facilities, drug formulation, and logistics solutions.