Overview
The Cell Manipulations Lab (CML) offers development, scale up and GMP production of novel cell products to support Phase I and II trials involving manipulated human cells covered under an approved IND. The services provided include cell selection, transduction for gene transfer, cryopreservation, storage, transportation and thawing in preparation for infusion. In addition, the CML provides consultation on cellular transfer clinical protocols from application to scale up and problem solving. The CML is supported by an independent Quality Assurance group providing compliance activities for both GMP and GTP systems through the Office of Research Compliance and Regulatory Affairs (ORCRA).
This Aseptic Processing Laboratory is a fully compliant GMP and GTP facility used to develop, produce, and characterize cell therapy products aseptically manufactured supporting Phase I and Phase II clinical trials. The CML is part of the Aseptic Processing Laboratory located within the Translational Cores Laboratories on the 11th floor of location S, Suite 400. The facility consists of approximately 10,000 ft2 of controlled-access space. Facility design, process design, construction and operations have been set up to be compliant with current Good Manufacturing Practices (cGMP) for manufacture of aseptic clinical materials in support of early phase clinical trials. A Type V Drug Master File (DMF) has been submitted with the FDA/CBER that describes the details of the CML. A letter of cross reference to the DMF is available upon request.
For further information regarding the Translational Core Laboratories, please contact the Director, Translational Cores Dr. Punam Malik, 513-636-8588. For information on the Cell Manipulation Laboratory, please contact Diana Nordling at 513-803-1063. For additional information about the Division of Experimental Hematology and Cancer Biology, please contact the Division Director Dr. Yi Zheng, 513- 636-0364. The Division of Experimental Hematology and Cancer Biology Translational Cores is located on the 7th floor of Location S (Research Foundation Building).
