Abstract

New ATMP production facilities often have to be implemented within very short time and a high degree of flexibility regarding product change and new process developments. A large German Biotech company has extended its CMO capacity for ATMPs and vaccines at its site in Eastern Germany with a new, very flexible biotech facility. The case study will provide an overview on the project development from initiation phase, via Concept Design and all Engineering phases, fast-track modular building construction, implementation of HVAC, cleanrooms, biotech equipment for upstream and downstream processing, media and buffer systems and further necessary periphery. Specific requirements for a multi-purpose vaccine production facility will be outlined. Further key points are:

• production of ATMPs, GTMPs, virus vaccines, including cancer vaccines
• biosafety level 2 and cleanroom class B design, implementation and operation
• attention points of single-use equipment and application
• fast track modular building using concrete steel prefab systems
• supply chain management for single use material in pandemic environment
• strategies for post pandemic use and application of the facility for GTMPs