Receipt, Storage, Preparation, and Dispensing of In Vivo Gene Therapy

An overview of the key considerations associated with receiving, storing, preparing, and dispensing in vivo gene therapies



An institution should have standard operating procedures in place for the receipt, storage, preparation and dispensing of gene therapy products1

Receipt and Storage

A gene therapy product should be received and stored in a specifically assigned room by authorised, trained staff.2,3 An example of the workflow is shown in the figure

Procedure for Receiving and Storing Gene Therapy Products


Figure adapted from Vulto AG, et al. 20073. *When gene medicines are delivered, the secondary packaging is guaranteed as not contaminated; If the vial is damaged, the primary packaging should follow the decontamination process; Location of storage must ensure that no unauthorised person can gain access, and there is no undue exposure of hospital staff to the product. A biohazard label may be required on the door to the storage room, depending on the biosafety level of the stored gene medicine.

The universal biohazard warning symbol should be included on all gene therapy products and posted on storage units and at the entrance to any room where the agent is present2


The following should also be provided at the entrance2,3



A gene therapy product prescription should be checked based on normal pharmacy procedure3

When a therapy is new to the institution, an accountability log can be a useful means for tracing steps in the handling of the gene therapy product3