Designed as a multi-use cleanroom facility
The University of Rochester Medical Center (URMC) has opened a new facility that will enable researchers to create, study, and ultimately use stem cells in early-phase experimental human therapies.
The 3,600ft2 Upstate Stem Cell cGMP Facility was created with US$3.5m in funding from the Empire State Stem Cell Board. It consists of three separate labs that can each support different cell production projects and is located in the URMC’s DelMonte Neuromedicine Research Institute. It is designed to be a multi-use, cleanroom facility, with high flexibility and versatility, for the production of clinical grade therapeutics.
To meet cGMP requirements the facility incorporates several design features including redundant air handling systems, walls covered with a fibreglass gel coat that aids in cleaning, and a building monitoring system that enables staff to monitor remotely air quality and room and equipment parameters 24 hours a day.
The facility is unidirectional flow, meaning that researchers and materials enter the lab through an air lock and depart through a different exit to ensure that contamination from the outside is not carried into the facility or among different labs.
This facility represents the key bridge to early stage trials in humans
More than 40 labs at URMC are working with stem cells. These labs employ more than 260 scientists and technicians and collectively have more the $80m in total research funding.
“This facility represents the key bridge to early stage trials in humans,” said Mark Noble, director of the URMC Stem Cell and Regenerative Medicine Institute. “We are now poised for early stage clinical studies in a range of conditions, including efforts to repair damage to the central nervous system, re-grow bone and cartilage, and even selectively target and destroy the stem cells that are the source of some forms of cancer.”
Several pending projects will immediately begin using the facility, including two investigations into the use of glial progenitor cells; the development of a new method to grow mesenchymal stem cells, the cells responsible for healing bones and keeping them healthy; a project that will produce antibodies for use against bone infections; and a new approach to use retinal stem cells to restore vision in persons with age-related macular degeneration.
“This state-of-the-art facility will help take the basic research findings of the state's outstanding scientists and help move them into the clinic, all the while ensuring that any cell products are produced in accordance with the strictest standards for use in human patients,” said State Health Commissioner Nirav Shah.
The Upstate Stem Cell cGMP Facility is staffed by executive director Mike Fiske, who has developed and overseen operations at similar facilities in the private sector for Wyeth and Genencor International, and two technicians.