The patient's own cells leave the body, and they have to come back.
In an autologous gene therapy, the medicine starts as the patient's own blood. It leaves the body, gets stored and shipped, is modified in a lab, and comes back for infusion. Every handoff is a chance to lose track of it, and a therapy made for one person can't go to anyone else. The chain of custody has to prove, at every step, whose cells these are, who handled them, and that they stayed at the right temperature.