We are very happy to annouce that the GMP facility name changed from Upstate Stem Cell cGMP Facility (USCGF) to UofR Cell Therapy Manufacturing Facility (UofR - CTMF), the reason is to reflect that the facility has been working with multiple cell therapies and not only with stem cells. The new name being more representative of the services provided by the Facility.
The new name will be phased in and in the meantime both names are equivalent.
USCGF is in cancer immunotherapy clinical trials with Torque Therapeutics
University of Rochester, NY, April 16, 2019- the UofR Cell Therapy Manufacturing Facility (UofR - CTMF), a Good Manufacturing Practice Laboratory at the University of Rochester, founded by Vice-Dean Steve Dewhurst and directed by Luisa Caetano Davies, is working in coordination with Torque Therapeutics (Cambridge, Massachusetts) to produce autologous TRQ-1501 Deep IL-15 Primed T cells for Phase 1-2 clinical trials in patients with selected, relapsed or refractory, solid tumors and lymphomas.The clinical trial started on February 20th.
At the UofR-CTMF, the manufacture of TRQ-1501 is taking place in 2 state-of-the-art (ISO class 6) manufacturing suites with highly skilled technicians and scientists experienced in the production of cell-based therapies, cell culture, immunotherapy and quality control/assurance. Important partners in this endeavor are UR Flow Core, UR Microbiology Clinical lab and UR Immunology Center Core.
This is a significant milestone for the UofR-CTMF as this is the first time that a cancer immunotherapy product produced in our GMP laboratory will be administered to a human subject, and approximately 80 patients are to be enrolled in the trial. TRQ-1501 is an investigational immune cell therapy produced from a patient’s own T cells, which are primed to target multiple tumor-associated antigens and loaded with Deep IL-15 (a multimer of IL-15 cytokine) anchored to the T cells’ surface.
This immunotherapy has the capability to target tumors that express multiple heterogeneous antigens, the ability to overcome the immunosuppressive microenvironment that shuts down T cell function, and only requires outpatient treatment, with a high margin of safety.
Additional details about Torque’s Phase 1 study may be found at www.clinicaltrials.gov (study identifier NCT03815682): “A Phase 1/1b Open-Label Multi-Center Study to Characterize the Safety and Tolerability of TRQ-1501 in Patients with Relapsed/Refractory Solid Tumors and Lymphomas
Therapy for macular degeneration using stem cell-derived human retinal pigment epithelium
“We selected the UofR - CTMF to create clinical grade Retinal Pigment Epithelial Stem Cell Lines for future clinical applications. The staff is highly experienced and knowledgeable and respond rapidly to our questions—they are part of our team!”
- Sally Temple, Ph.D. New York Neural Stem Cell Institute, AMC
Transplantation of human glial progenitor cells as a treatment for multiple sclerosis
“This facility is a boon to researchers across the state. It will specifically help accelerate our lab’s work in multiple sclerosis and other neurological disorders be enabling us to generate cell lines suitable for early phase clinical studies.”
- Steve Goldman , M.D. Ph.D., University of Rochester
Tissue engineered massive allografts for healing large segmental long bone defects
“The UofR Cell Therapy Manufacturing Facility has become an essential asset to the progression of our tissue engineering research programs from the lab to the clinic.”
- Hani Awad Ph.D., University of Rochester
Monoclonal antibody passive immunization for MRSA
"We chose the UofR Cell Therapy Manufacturing Facility to manufacture our monoclonal antibody for large animal testing of our passive immunization for S. aureus implant-associated osteomyelitis due to its great team, and ability to readily generate drug through our Phase 1 clinical trial. Given the great demand for first-in-man mAb, I highly recommend this facility for early stage clinical trials.”
- Eddie Schwarz Ph.D., University of Rochester
"The UofR Cell Therapy Manufacturing Facility is a model for contract development and manufacturing organizations looking to provide maximum flexibility for its clients. The skilled operations team can utilize three separate processing areas with validated equipment and a comprehensive quality system to process a variety of mammalian cell lines simultaneously."
- Rick Lawless, BTEC, North Carolina
“We are very impressed with the UofR Cell Therapy Manufacturing Facility at URMC, and consider it as one of the top academic GMP facilities within biologics manufacturers”
- Gerhard Bauer, UC Davis
"Dr. Luisa Davies and her UofR - CTMF colleagues provide a superb biomanufacturing curriculum and hands-on practicum experiences to develop next generation leaders and skilled professionals for the biomanufacturing industry. USCGF leads the fall semester MBI406 course and ensures trainees have a strong technical background and real-world opportunities to meet and learn from experts within the cGMP community".
- Tracey Baas, PhD , Assistant Dean of Graduate Student & Postdoctoral Success at The University of Texas at San Antonio
GMP astrocytes produced from embryonic glial progenitor cells for spinal cord repair
“This facility represents the key bridge to early stage trials in humans and will enable us to move forward with studies in a wide range of conditions, including efforts to repair CNS damage, regrow bone and cartilage, and even target cancer stem cells.”
- Mark Nobel Ph.D., University of Rochester
Executive Director, UofR Cell Therapy Manufacturing Facility (UofR - CTMF)