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