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 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.

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
  - 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 supernatant
Production, Quality Control (QC) and Quality Assurance (QA) done by different individuals