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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)
    • cGMP working environmentStem 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 vialingcells
  • 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?GMP cells

  • 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 Shares

Brianna Kalicharan, Ph.D.

Interim Co-Director
UofR Cell Therapy Manufacturing Facility (UofR- CTMF)
(585) 276-6208
Email Brianna Kalicharan