Overview
Cell Manipulations Lab
The Cell Manipulations Lab, a cleanroom designed and cGMP validated to support Phase I and II trials involving manipulated human cells, offers a full Menu of Services available to all Cincinnati Children's investigators and may be available to outside investigators. Please contact Lilith Reeves (513-636-3468) or Tom Leemhuis, PhD (513-558-1553) for additional information.
The Cell Manipulations Laboratory (CML) was designed, built, and validated, in consultation with the FDA, to provide a suitable environment for ex-vivo cell manipulations for Phase I & II clinical trials consistent with requirements for Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP). The facility is dedicated to the selection, expansion transduction, and/or other culture aspects of producing extensively manipulated cell products for clinical trial applications. The CML management and staff have documented training in GTP and GMP processes and have successfully performed manipulations in support of IND directed gene transfer trials as well as other protocol driven clinical processes.
The physical properties of the CML include approximately 450 ft2 of terminal HEPA filtered cleanroom space, including two (approx.) 100 ft2 ISO Class 7 (Cleanroom class 10,000) cell processing suites, a common equipment area, a gowning room, and a de-gowning room. There is also an additional 150 ft2 of administrative and storage space-for a total area of 600 ft2. The facility is divided into functional areas to assure separation of activities and thus maximize product segregation. Equipment in each cell processing suite includes a Low O2 - CO2 incubator, Class 5 (cleanroom class 100) biosafety cabinet, inverted microscope and dedicated support equipment. The common room houses a refrigerator, a -80 C freezer, Isolex and CliniMacs cell separation devices, microscope and a controlled rate freezer. All critical equipment is connected to a central alarm system and has been validated to function properly prior to use with clearly defined ongoing function verification and maintenance safeguards. The laboratory operates under an Institutional Biosafety Committee (IBC) approved BL1 rDNA protocol and all materials are shown to comply with IBC protocol specifications prior to entry into the laboratory.
The facility is operated according to approved Standard Operating Procedures. These SOP's direct controlled access, material entry specifications and flow, personnel entry procedures and flow, waste management, equipment control and alarming, pressure differential monitoring, and environmental cleaning, sanitization and particulate monitoring. Room air pressure differentials are continually monitored for compliance with cleanroom standards. An extensive and detailed viable and non-viable particulate environmental monitoring system fully meets the US FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice (September, 2004). Processes are validated in compliance with regulatory requirements applicable to each specific protocol.
The CML is located in the Research Foundation building at Cincinnati Children's Hospital Medical Center, within walking distance from the inpatient and outpatient treatment areas where product infusions will occur. The facility is jointly operated by Hoxworth Blood Center personnel and the Division of Experimental Hematology of the Cincinnati Children's Research Foundation and may be made available to other CCHMC and outside investigators. The CML Menu of Services outlines specific points to be addressed in developing an agreement tailored to specific investigator needs. The services may range from facility use to Quality Assurance and/or GMP development support to full process implementation and product manufacturing.
Contact Us
For further information regarding the Cell Manipulations Laboratory (CML), please contact Dr. Tom Leemhuis at 513-558-1553 or Lilith Reeves at 513-636-3468.
For additional information, please contact Dr. Yi Zheng, Division of Experimental Hematology and Cancer Biology, at 513-636-0364. The Division of Experimental Hematology and Cancer Biology can be found in Room 7.205 of Location S (Research Foundation Building).
