McGrath completed construction of a new cGMP Flexible Single Use Biologics Manufacturing Suite in an operational production facility. This suite of approximately 5000 square feet will provide late stage, Phase III to commercial capabilities at 2000L fed-batch cell culture and downstream processing. The project included a clean cold room and reworking existing plant locker rooms that needed to remain active at all times. Material and personnel flows will be unidirectional and will utilize airlocks.
The processing suites are classified ISO-7 with ISO 8 Corridors. Utility drops to support the bioreactors include plant air, oxygen, carbon dioxide, and nitrogen all piped to control panels then to distribution panels. Other services included glycol temperature control units with associated piping and WFI piping. New dedicated HVAC units were installed with active pressure controls, and access control for unidirectional personnel flows.
Work Performed
Services: Construction Manager at Risk / General Contractor
Self-Perform Work: Equipment Installation, Structural Concrete, Demolition
Project Partners
Engineer: NNE Pharmaplan
Value
$4 Million
