Gene Therapy Facility Renovation
Project Overview
GBA provided design services for renovating an existing 50,000-square-foot precast warehouse building. The project involved a tenant finish and building modifications supporting the installation of new, manufacturing cleanroom PODS in a leased building for use in a clinical-scale gene therapy process.
GBA provided onsite engineering staff to augment the client’s engineering staff to assist in construction as-built review, punch list management, equipment start-up troubleshooting, change control documentation, P&ID, SOP, and Batch Record generation and process development support. GBA also worked closely with the owner to meet tight budget and schedule constraints.
Ancillary spaces included labs, cold rooms/freezers, a thaw area, a CRT warehouse, packaging and inspection.
Services Provided:
- Estimating
- Architectural Design
- Mechanical Design
- Electrical Design
- Fire Protection design
Project Elements:
- BSL2 labs in prefabricated cleanroom PODs
- Upgrades to chilled water and heating hot water systems, UPS, generator, and new service entrance
- Coordination with city and state regulators for code compliance
GBA managed multiple phases over three years, delivering:
- ARC Flash Study
- Facility renovations of office, freezer farm, warehouse, mechanical systems, and cold rooms
- Two phases of modular cleanroom PODs totaling 12,500 SF of aseptic production
- A 1,500-square-foot production suite
- Design of QC, EM, and IQ labs
- Facility regulatory documentation and file management system design