CGMP Cell Culture Launch Facility Concept

IPS designed a new 4x2000L (maximum production scale) multi-product, multi-phase monoclonal antibody and vaccine production facility. The greenfield site was designed to seed, scale up, harvest, and purify cell culture and vaccine products utilizing up to 100% single-use systems. The concept included six manufacturing modules of which four were identical to allow for process flexibility of different unit operations, scales, and phases of material. The other two were designed to accommodate formulation of buffer and/or media as well as other additives.

In addition to the core manufacturing, the concept included pilot operations, flexible development and quality control laboratories, warehousing, cold storage, central utility plant, and administrative block.

• SU harvest technologies
• Prefab modules with cPVC modular wall & ceiling systems
• Full wash module
• 3D REVIT® model utilized for concept development, equipment arrangements, preconstruction, estimating
• Process utility & air handling super skids
• Native delta v platform
• MES, RFID and LIMS Systems