RAPA Therapeutics cGMP Laboratory Renovation/Build-out

Rockville, MD

Project Synopsis

LSY assisted RAPA Therapeutics with the design and construction of this new cGMP facility. The facility supports FDA Phase-3 human cell therapy clinical trials, focusing on treatments for cancer and auto-immune diseases. The facility comprises two clean rooms with associated anterooms (all at ISO 7) for pursuing multiple lines of study simultaneously. Spaces in support of the clean rooms include Cell/Materials Intake and Released Materials rooms, a Cryo-Preservation room, and spaces supporting two phases of gowning. Other ancillary spaces include an equipment area supporting R&D functions in the adjacent laboratory, an office, and a service corridor allowing equipment and materials movement without interfering with clean room function.

The project space is a one-story commercial tenant space, slab-on-grade, and was shell space prior to the build-out. The design included reinforcement of the existing roofing structure for a dedicated clean room HVAC unit, installation of an emergency generator to support the clean rooms and lab equipment, and consideration of the need to support a modular clean room ceiling system from the roof structure.

LSY investigated use of both stick-built and modular clean room systems, ultimately recommending that the client utilize a premanufactured modular panelized system. This involved a basic cost/benefit analysis of these two systems, and incorporated additional value-based information derived from the client’s specific needs. Clean room classification, pressure drawings, and HVAC zoning criteria were developed for the MEP designer.

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