UC Davis GMP Facility
directed by Gerhard Bauer
(916) 703-9305
http://www.ucdmc.ucdavis.edu/stemcellresearch/gmp/index.html
a member since 3/8/2010

Contact Info

For information contact
Gerhard Bauer.

(916) 703-9305
University of California Davis
GMP Facility, Institute for Regenerative Cures
2921 Stockton Blvd.
Sacramento, CA 95817

USA
(916) 703-9305
(916) 703-9310

Services Provided

This facility provides research grade material and offers production support to both Academics and Companies.

Misc Services

  • Regulatory and IND support

Biologics Produced

  • working cell banks
  • Vaccines
  • Tumor Vaccines
  • Pluripotent Stem Cells
  • mesenchymal stromal cells
  • Isolated and Expanded T-Cells
  • Hematopoietic Progenitor Cells
  • Hematopoietic Cell Isolations
  • GMP grade FACS sorted cell populations; human embryonic stem cells; human induced pluripotent stem cells; differentiated tissues from these cell types.
  • Gene-modified T-Cells
  • full GMP facility. Master cell banks

Vector Support

  • Retrovirus
  • Lentivirus

About this facility

The GMP facility in the CIRM funded Institute for Regenerative cures at the University of California Davis, School of Medicine, is a multi-use, 6 manufacturing suite, Class 10,000 facility for manufacturing of clinically applicable products under current Good Tissue Practice, current Good Manufacturing Practice and USP 797.

All 6 manufacturing rooms are independent of each other, applying one way personnel, product and waste flow. 6 different products can be manufactured without interfering with each other. The manufacturing, entry and exit areas are separated by air pressure gradients. An elaborate interlock system controls opening and closing of access doors, therefore avoiding cross-contamination of products by air turbulences.

The GMP facility features an electronically controlled and automatically monitored environment, with manual 7 day week manual monitoring on top of it. A strict QC/QA program with environmental cleaning and monitoring procedures is implemented to assure strict quality control of facility and products, and freedom from microbiological contamination.

Additional features: Manufacturing room pressurization can be switched from positive to negative, to allow clinical grade FACS sorting and vector / vaccine production. One  manufacturing room is equipped with a GMP grade hot cell for the manufacturing of PET imaging reagents.

In a type C meeting with FDA, the plans for the facility were discussed with and accepted by the agency.

In all, this facility provides a state of the art environment for the manufacturing of novel therapeutics for human clinical applications.