Comprehensive Engineering & Design

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
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