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Upstate Cell Therapy cGMP Facility - Good Manufacturing Practice Laboratory

The Upstate Cell Therapy cGMP 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)
    • 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
      • 25 L 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 supernadant
  • 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 & Qualification
  • Quality Assurance / Quality Control
  • Validation & Environmental Control
  • Regulatory Guidance​

Media

Contact

Luisa Caetano Davies

Luisa Caetano-Davies
Executive Director, Upstate Cell Therapy cGMP Facility
585.276.6208
E-mail