Cell Processing and Vector Production
(Adrian Gee, Ph.D., Director)
Cellular and gene therapies offer great promise as new approaches to treat a variety of diseases.
Preparation of therapeutic cells and gene therapy products is regulated by the Food and Drug
Administration and must be carried out under Good Manufacturing Practice (GMP) laws.
This mission of this core, located on the 11th floor of the Feigin Center at Texas Children's Hospital, is to transition new cellular and gene therapies from the research laboratory into clinical trials, by manufacturing therapeutic grade products under GMP conditions.
The core consists of two Class10,000 areas; one for preparation of somatic cell therapy products (including hematopoietic, hepatic, cardiac and pancreatic cells), and the second for production of adenoviral and retroviral vectors. There is a quality assurance and control (QAQC) laboratory that provides facility and product testing services (endotoxin, mycoplasma, bioburden etc.). Both facilities are designated national laboratories by the National Institutes of Health.
In addition to providing manufacturing services, staff can assist in pre-clinical research, regulatory submissions and development of required documentation. Charges are based on the type and quantity of product manufactured, and are calculated on the cost of materials and labor, plus a supplementary hourly charge to cover facility use and support services. QAQC testing charges are based on test complexity and turnaround time. Cost estimates can be obtained by contacting the appropriate core representative shown below.
For cellular therapy products contact:
Dr. Adrian Gee: 832-824-4214
Fax: 832-825-4668
E-mail:apgee@txccc.org
For viral vectors contact:
Dr. Zhuyong Mei: 832-824-4175
Fax: 832-825-4668
Email: zxmei@txccc.org
For product testing contact:
Deborah Lyon: 832-824-4811
Fax: 832-825-4668
E-mail: dllyon@txccc.org
Also please visit our CAGT - GMP Site