C-DOCTOR Manufacturing & GMP Resources

City of Hope Biological & Cellular GMP Manufacturing Facility – David Hsu (dhsu@coh.org) or Joseph Gold (jogold@coh.org)
The Center for Biomedicine & Genetics (CBG) is a California-licensed, 20, 000 square foot, multi-product biologics manufacturing facility. With twelve ISO 7 production rooms in three product type “zones”, a dedicated aseptic fill suite and a staff with extensive biopharmaceutical experience, the CBG is capable of producing virtually any type of biologic at scales suitable for Phase I through Phase II clinical trials. The Cellular Therapies Production Center (CTPC) is a 6,800 square foot cell therapy manufacturing facility comprising six ISO 7 production rooms. The CTPC supports the production of manipulated autologous and allogeneic cell therapies.

UC Davis GMP Lab – Gerhard Bauer (gerhard.bauer@ucdavis.edu)
UC Davis’ Good Manufacturing Practice facility in Sacramento features six manufacturing rooms with Class 10,000, multi-use cleanroom capabilities. It also offers an associated product scale-up and testing lab. Unique features include a GMP-grade FACS sorter, switchable positive-negative room pressurization for gene therapy vector manufacturing, and a hot cell for clinical grade PET reagent manufacturing.

Stanford Laboratory for Cell & Gene Medicine – David DiGiusto (digiusto@stanford.edu)
To produce individualized therapies for phases one and two clinical trials.

UCLA Janis V. Georgi Flow Cytometry Core Facility – Zoran Galic (zgalic@ucla.edu)
Instrumentation and technical and professional assistance for performing laser-based analytic flow cytometry, image cytometry and cell sorting, as well as mass cytometry. The facility operates one three laser BD-LSRFortessa X-20 analyzer, two five-laser BD LSRII analyzers, one three-laser BD-LSR II analyzer with a high throughput option, one ImageStreamx MarkII imaging flow cytometer, and for cell sorting, three BD FACSAria high-speed cell sorters, a Helios (a CYTOF system) mass cytometer and a RoboSep, an automated immunomagnetic bead cell separator from STEMCELL Technologies

UCLA Flow Cytometry Core – Felicia Codrea (fcodrea@mednet.ucla.edu)

UCLA hESC and IPS Cell Core – Jinghua Tang (jinghuatang@mednet.ucla.edu) or Saravanan Karumbayaram (skarumbayaram@mednet.ucla.edu)
Culturing of hESCs and IPS cells

UCLA Cellular Bioenergetics Core – Laurent Vergnes (lvergnes@ucla.edu)
Measure of cellular respiration and glycolysis from cells, mitochondria, tissues, worm and yeast.

UCLA Immune Assessment Core – Maura Rossetti (mrossetti@mednet.ucla.edu)
Standardized and customizable multi-parameter flow cytometry, immunoassays and functional assays for assessing various immune cell functions, including T cells, B cells, NK cells, monocytes and granulocytes.

UCLA Immuno/BioSpot Core – Brent Gordon (brgordon@ucla.edu)
Detection, quantification, and qualification of biological spot assays and single-cell related analyses, including ELISPOT, colony counting, plaque assays, FluoroSpot, cell viability tests, apoptosis tests, in vivo/in vitro cytotoxicity measurements using cells labeled with fluorescent dyes, histochemistry stains, genotoxicity assays, multi-color intracellular/surface quantification, etc.

UCLA Human Gene & Cell Therapy Program & GMP Facility – Vance Handley (vhandley@mednet.ucla.edu)
Clinical cell and gene processing laboratories infrastructure; supports documentation and monitoring oversight of gene and cell product manufacture