Upstate Stem Cell cGMP Facility - Good Manufacturing Practice Laboratory
With funding from the Empire State Stem Cell Board (NYSTEM), in 2011, the University of Rochester Medical Center constructed, the Upstate Stem cGMP Facility (USCGF), a fully validated facility designed for the manufacturing of therapy products for clinical trials.
The USCGF offers 3 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.
- 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
- Master / Working cell bank Options
- Control Rate Freezer for cryopreservation
- Immune cells (PBMC, T-Cells, Dendritic, Lymphocytes)
- Genetically modified T cells (CAR-T )
- Monoclonal Antibodies and recombinant Protein production
- Bacterial / mammalian host
- 25 L 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 supernadant
- Production, Quality Control (QC) and Quality Assurance (QA) done by different individuals
- 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 & Qualification
- Quality Assurance / Quality Control
- Validation & Environmental Control
- Regulatory Guidance
Director, Upstate Stem Cell cGMP Facility