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GMP Cell Manipulation
Cell Manipulations: Supporting Clinical Trials through Cell Preparation
The Cellular Manipulation Laboratory (CML) is part of the Translational Cores at Cincinnati Children’s Hospital. We support the development, scale up and processing of innovative cell based therapies for Phase I/II clinical studies. CML ensures reproducible large scale production of therapeutic cells under strict quality control and safety conditions required by the FDA for human studies.
We partner with researchers to carry potential new cell-based therapies from research to clinic by working closely with each Sponsor/PI, and by developing a process and timeline that meets therapeutic needs and regulatory requirements.
CML Services include:
Enrichment or depletion of specific cell subsets
Genetic modification (transduction)
Cellular stability studies
Thaw and preparation for infusion
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
All more-than-minimally manipulated cell and tissue procedures are performed in the Aseptic Processing Laboratory clean rooms following GMP and GTP quality compliance requirements. All procedures utilized by the CML were developed to meet FACT standards, and labels are designed to meet the requirements of ISBT-28.
The CML holds a Type V Master File (MF-BB) with the FDA/CBER that describes the details of the facility and process control. A letter of cross reference to the DMF is available upon request. CML staff have experience in providing investigators support in development of relevant CMC (Chemistry Manufacturing and Control) section for both INDs and IDEs.
Researchers and clinicians can contact us for more information and how we can help you with your cell therapy and gene transfer needs. Clinical Coordinators should contact email@example.com to schedule patient procedures.