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

Services

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