Concept and organization of a clinical gene therapy lab

Designing a dedicated clinical facility to meet the needs of existing and developing Gene Therapy Protocols presents a unique challenge. Here, we review some of the issues we faced and share some of our design concepts. An optimal Clinical Gene Therapy Lab must meet relevant regulatory guidelines, interface with other hospital labs as well as the clinic and patient care areas, be efficient and flexible in utilization of space, and have the potential to meet future needs without continual renovation. As clinical science expands to include more gene transfer approaches, specific laboratory areas for this type of work will become increasingly necessary.