Operations

The use of the Laboratory for Cell and Gene Medicine (LCGM) resources must be consistent with Stanford's mission to develop innovative cell and gene based therapies for treatment of pediatric and adult patients with incurable disease. The Operations team at LCGM works to ensure that our resources and facility are always dialed in and ready for peak performance. Their responsibilities include:

  • Ensuring buildings, facilities and site are maintained to fully meet cGMP, Regulatory and LCGM guidelines
  • Managing outsourced site services and confirm cGMP compliance
  • Maintaining the interface with support units to ensure services provided support safe manufacturing operations
  • Rapidly diagnose and perform corrective and preventive action following mechanical systems failure
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The facility is designed to accommodate the production of Biosafety level I/II biologicals with separate controlled spaces for cell and vector production, each with dedicated air handling systems to prevent cross contamination of products.  Storage is strictly segregated and access to materials associated with projects subject to cGMP regulation si availble only to authorized personnel.

Preventative Maintenance is performed routinely.

It is important that our equipment be functioning at all times. The Operations and Facilities teams schedule routine preventative maintenance and maintain records of all maintenance. In addition, monitors and alarms are enabled throughout the facility to detect changes in airflow, temperature and performance.