Northern California's largest academic Good Manufacturing Practice (GMP) laboratory is now open and available to California research scientists. The new facility, located on the UC Davis Sacramento campus, is a key component of the UC Davis Institute for Regenerative Cures, a facility supported by the California Institute for Regenerative Medicine.

This 7,000 square-foot, custom-designed laboratory suite offers switchable manufacturing room pressurization, providing a strictly controlled environment for cellular manufacturing, as well as the ideal setting for producing gene therapy vectors. Additionally, it features the first clinical grade fluorescent activated cell sorter in a true biosafety cabinet, and the first GMP-grade Hot Cell chamber for the manufacture of novel, clinical grade positron emission tomography reagents.

For more information, or to inquire about the availability of the GMP facility for research, please contact Gerhard Bauer at gerhard.bauer@ucdmc.ucdavis.edu

Pass-throughs allow spatial and temporal sparation of products as requested by FDA in the pre-facility meeting.

 Guiding Principles

• Adherence to GMP regulations as required by the FDA

• Precisely followed Standard Operating Procedure

• Strict Quality Control (QC) and Quality Assurance (QA), with each being done by different individuals

• Testing of final products according to FDA guidance and requirements 
• Rigorous personnel training and proficiency testing
• Meticulous documentation and record keeping
• Readiness for audits

GMP Laboratory Goal 

• The manufacture of quality products for clinical application