CAGT - Gene Vector Laboratory

The Gene Vector Laboratory is located in the Feigin Center of the Baylor-affiliated Texas Children's Hospital, the largest pediatric hospital in the nation. The laboratory occupies approximately 1,600 square feet on the 11th floor, is fully self-contained, and has extensive dedicated equipment required for large-scale vector production. The design follows the applicable specifications of current Good Manufacturing Practices for Finished Pharmaceuticals (CFR Title 21, Part 211, Sub-part C).

The laboratory is organized into six distinct areas: 1) a reception area used for receipt of supplies and materials as well as an area for storing the central supply of CO2 gas and LN2, freezer and storage units; 2) a quarantine tissue culture room; 3) a molecular laboratory for in-house vector and procedure development; 4) a gowning and air-lock room that separates the receiving, quarantine and molecular laboratory from the production areas; 5) Suite A, the primary adenovirus production suite which may also function as a retrovirus or ex-vivo transduction suite; and 6) Suite B, composed of three independent suites. Suites B2 and B3 are separated from Suite B1 by double weight glass doors and a positive air pressure differential. Suite B1 functions as a clean area between vector preparations in Suites B2 and B3.

Organizational structure is based on production teams, currently two teams each composed of two technologists, under the direction of the Laboratory Supervisor. The goal of the laboratory is to establish and follow uncompromising, scientifically sound standard conditions for production of gene therapy vectors used in Phase I/ II clinical trials.

This is a National Gene Vector Laboratory, and will make clinical grade adenoviral vectors without charge for investigators sponsored by the NGVL http://www.ngvl.org