UofR Cell Therapy Manufacturing Facility (UofR- CTMF)
Good Manufacturing Practice (GMP) Laboratory
The UofR Cell Therapy Manufacturing Facility (UofR- CTMF) is a GMP Facility offers three state-of-the-art (ISO 6) manufacturing suites with highly skilled technical personnel to University Scientists, Academic, and Industry partners for a diverse palette of services.
The final goal is to manufacture products with quality for clinical application.
Services
- Process Development and scale-up for GMP Manufacturing for Clinical trials (Phase I/II)
Stem cells (Adult, ESC, iPSC, MSC) for autologous or allogeneic transplants
- Suspension/Adherent
- Master / Working cell bank options
- Control rate freezer for cryopreservation
- Immune cells (PBMC, T-Cells, Monocytes, Dendritic, Lymphocytes)
- Deep- primed T-cells
- Genetically modified T-cells (CAR-T )
- Monoclonal antibodies and recombinant protein production
- Bacterial / mammalian host
- 25L fermentation / cell culture
- Gene therapy vector production (clinical grade plasmid DNA and retroviral vectors)
- Vaccine formulation and vialing
- Development of analytical methods for product characterization and release
- Quality control in-process and release testing of intermediate and final products
- Gram stain
- Endotoxin (LAL test)
- 14 day sterility test
- Real-Time PCR (qPCR) for mycoplasma detection in cells
- Mycoplasma detection in cell supernatant
- Production, Quality Control (QC), and Quality Assurance (QA) done by different individuals
Why Us?
- We work in collaboration with clients in process development
- Competitive rates
- Flexible scheduling
- GMP product storage
- Access to University of Rochester "Core Facilities"
- Analytical methods development and qualification
- Quality Assurance / Quality Control
- Validation and environmental control
- Regulatory guidance
Media
Contact Us
Brianna Kalicharan, Ph.D.
Facility Director
UofR Cell Therapy Manufacturing Facility (UofR- CTMF)
(585) 276-6208
Email Brianna Kalicharan