GMP Facility

GMP Facility at the Robertson CT2

The Robertson Clinical and Translational Cell Therapy Program cGMP facilities are designed with architectural features and finishes in accordance with US Food and Drug Administration guidance and regulations as well as international requirements for controlled cleanroom manufacturing environments and aseptic processing.

  • Floors and other exposed surfaces are designed to withstand the necessary cleaning and sanitization that ensure product purity and patient safety.
  • HEPA filter and air-handling units are configured to deliver particulate-free air at a positive air pressure respective to surrounding rooms and spaces; the air quality meets class 10,000 (ISO class 7) standards.
  • Critical parameters (temperature, pressure, and humidity) are continually monitored.
  • Environmental monitoring is performed to assure microbiological control.
  • All manufacturing equipment and utilities are validated in accordance with biopharmaceutical standards (IQ/OQ/PQ). Standard operating procedures assure that all systems are properly maintained and functional.
  • Access to the facility is controlled.

Available equipment includes:

  • Biological safety cabinets (class 1,000)
  • CO2 incubators
  • Room temperature and cold storage (4° and -20°C)
  • Auxiliary equipment including centrifuges and microscopes
  • Stainless steel work surfaces

In addition to the clean rooms, facilities contain designated gowning areas, preparatory labs, shipping and receiving stations, and cryostorage areas. They also employ robust sample identification and traceability systems as well as electronic document control systems as part of a centralized quality infrastructure. These systems and other quality control testing, including BacT/ALERT® Microbial Detection and Endotoxin testing, are available to all facility users. Specialty analytical capabilities are available for cell enumeration, viability assessment, flow cytometry, biological potency, and functional assays.

For more information, contact Tracy Gentry, director of the GMP Lab, or Rebecca Durham, director of Translational Cell Therapy Services for the Duke Translational Research Institute (DTRI).