Translational Core Laboratory
Cell Manipulations Laboratory

Cell Manipulations Laboratory

The Cell Manipulations Laboratory's experienced scientists can help you develop and scale up your ex-vivo gene transfer and cell therapy clinical trials or simply transfer your existing at-scale technology to our clean facilities which will enable you to move your research to a safe and effective patient treatment plan.

CML offers more-than-minimally manipulated cell and tissue procedures performed aseptically in our cleanroom in accordance with GMP / GTP quality compliance requirements. All customized support provided by CML is performed on a fee-for-service basis.

Researchers in the Cell Manipulations Laboratory have experience culturing a wide variety of primary human cell types including:

  • Hematopoietic progenitors and stem cells
  • T lymphocytes and other immune cells
  • Embryonic and induced pluripotent stem cells


CML services include:

  • Enrichment or depletion of specific cell subsets
  • Genetic modification (transduction)
  • Expansion, differentiation
  • Product cryopreservation
  • Cellular stability studies
  • Thaw and preparation for infusion 

The CML is compliant with GMP (21 CFR 211), GTP (21 CFR 1271) and holds a Type V Master File (MF-BB) with the FDA.

GMP Cleanroom Facility

The production facility consists of approximately 2,000 square feet of controlled-access space that includes four ISO Class 7 clean room suites equipped with ISO Class 5 biosafety cabinets for aseptic processing.

The clean room facility offers the following features:

  • Certified ISO Class 7 production suites with ISO Class 8 support areas
  • Integrated 24/7 Automated Particle Measuring System
  • Uninterrupted power supply and emergency power systems
  • Independent CO2 gas supply with automated backup
  • Independent HVAC system with redundant fan design
  • Integrated Building Management System with personnel Alarm Notification System
  • Independent Controlled Access System


Ask about Our Services

Contact us.

Researchers and clinicians can contact us for more information about how we can help you with your cell therapy and gene transfer needs. Clinical coordinators should email or call 513-636-6261 to schedule patient procedures.