As a direct result of strategic collaboration between leadership and faculty of the Duke Department of Surgery and the DTMI, Duke researchers can now develop cell-based products and molecular therapeutics in a specialized, multi-purpose facility that meets rigorous Good Manufacturing Practices (GMP) standards for production of clinical trial material.

Located in the Medical Sciences Research Building (MSRB I), the new clean suite facility contains a large preparatory room and two cell processing laboratories outfitted with state-of-the-art equipment. Each instrument in the shared
resource has been validated and will be continuously monitored according to FDA regulations.

• Basic requirements to use the suite include proficiency training (provided by the DTRI) and passing an exam on current GMP and cleaning methods for the space. 

• It is the responsibility of every investigator to train personnel in the conduct of research and protocol-specific procedures within the facility.

• Investigators are expected to provide disposable items they might need as well as items specific to their experiments. They can store and label these items in bins located in the facility’s preparatory area.

• Investigators will be able to download appropriate SOPs during the course of an experiment using a computer workstation located inside the suite.

• Investigators will be charged a minimal fee to cover ongoing associated costs including facility technicians and service contracts for equipment maintenance and calibration.

• The number of projects that may be run in the facility is restricted by its eight incubators, since only one set of cells can be placed in an incubator at any given time. Stringent cleaning procedures also preclude two researchers from using the facility simultaneously.

Investigators who would like to use the MSRB facility should contact Virginia Burns, PhD at (919) 668-4647 or virginia.burns@duke.edu to register for and complete required training, and subsequently schedule usage of the suite.