On Thursday, May 8, 2014, I had an opportunity to spend a few hours with Diana Nordling, the Director of Operations at the Cincinnati Children’s Hospital Translational Core Laboratory. Dr. van der Loo provided an interview and overview of the facility operation. This interview is available on the web here. The facility consists of a number of clean rooms, and classified BSL spaces along with a CLIA laboratory for cellular and molecular laboratory work. The GMP facility includes:
The Vector Production Facility is used for the aseptic manufacture of early-phase GMP products including, but not limited to, Retroviral, Adeno-associated Virus (AAV), Adenovirus (Ad) and Lentivirus vectors, Master Cell Banks, Master Viral Banks, and other vector systems at Biosafety Level 2 (BL2). The facility consists of three production rooms for concurrent production. The lab is equipped with scaleable single-use Wave Bioreactors, Tangential Flow Filtration (TFF) and Liquid Chromatography (LC) systems. The LC systems include an AKTAready for closed system clinical manufacturing and AKTAavant for development and scale-up.
The Cell Manipulations Laboratory is used for the processing of more-than-minimaly manipulated Somatic Cellular Therapy products made according to cGMP and GTP requirements. The laboratory currently consists of one processing area with the capability to expand to four additional processing rooms. One single product would be processed in this suite at a given time. The lab currently uses a CliniMACS® for cell isolation and provides cell expansion, processing, and transduction in support of gene therapy trials.
These facilities are used to develop the gene transfer procedures, the vectors and support clinical trial work. We often use the buzzword-personalized medicine, however often the traditional production facility for pharmaceuticals is far removed from the patient; this is not so at the Translational Core Laboratory. Often the laboratory staff are working with the patient, the physician, and the patient’s families during the acquisition of cells from the patient, processing the patient cells, combining the cells with the vectors used to deliver the gene therapy, transporting the modified cells back to the operating theater and finally infusing the therapy into the patient. Since this therapy involves living cells, there is a limited short-term window from start to finish. Taken in this context, the TCL staff are much more emotionally engaged with the patient and patient outcomes. Listening to Diana relate patient success stories was very heartwarming and illustrated the engagement of the staff when facilitating these treatments.