C-DOCTOR Manufacturing & GMP Resources
City of Hope Biological & Cellular GMP Manufacturing Facility – David Hsu (firstname.lastname@example.org) or Joseph Gold (email@example.com)
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 (firstname.lastname@example.org)
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 (email@example.com)
To produce individualized therapies for phases one and two clinical trials.
UCLA Janis V. Georgi Flow Cytometry Core Facility – Zoran Galic (firstname.lastname@example.org)
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 (email@example.com)
UCLA hESC and IPS Cell Core – Jinghua Tang (firstname.lastname@example.org) or Saravanan Karumbayaram (email@example.com)
Culturing of hESCs and IPS cells
UCLA Cellular Bioenergetics Core – Laurent Vergnes (firstname.lastname@example.org)
Measure of cellular respiration and glycolysis from cells, mitochondria, tissues, worm and yeast.
UCLA Immune Assessment Core – Maura Rossetti (email@example.com)
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 (firstname.lastname@example.org)
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 (email@example.com)
Clinical cell and gene processing laboratories infrastructure; supports documentation and monitoring oversight of gene and cell product manufacture