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