Transport and Administration of In Vivo Gene Therapy
A review of the considerations associated with the transport and administration of a gene therapy product
Procedures and policies for the safe transport and administration of gene therapy products are important to:1
Ensure the safety of healthcare professionals and patients
Protect the gene therapy product and the environment
Following its preparation and dispensing in the pharmacy, a gene therapy product can then be transported to the administration area
If possible, it should be transferred within walking distance of the pharmacy. This helps to reduce the risk of spills and contamination1
There are a number of recommendations when transporting a gene therapy product within a clinical facility, which include those listed below
The administration location of a gene therapy product will depend on the product’s biosafety level (BSL), risk assessment, and manufacturer’s guidance*2–6
Key recommendations for consideration at this stage are discussed below
*Please refer to local prescribing information.
Arrival of Gene Therapy Product
It is best practice that a gene therapy product is used immediately following preparation and that storage duration at the administration site is kept to a minimum2
To facilitate immediate use, the patient should be prepared for administration in a timely manner relative to product preparation2
BSL, biosafety level.
Personal Protective Equipment (PPE)
Administering staff and other personnel dealing with the product should be dressed, at a minimum, in a disposable gown and wearing sterile gloves, with use of further PPE, such as disposable face mask and goggles, depending on the product’s risk assessment2
The number of personnel present should be kept to a minimum2
The patient may move around the ward or outpatient department once the procedure is complete, providing containment of the gene therapy product is ensured2
However, this will depend on the product’s BSL, risk assessment, and route of administration2
Administrative logs should be completed and updated2
An accountability log is a means of tracing steps in the handling of a gene therapy product.2 It may be especially useful when a product is new to an institution2
A staff exposure log may be required, depending on the gene therapy product and local regulations.2 If used, any accidental exposures should be recorded in the log, which should be held centrally, for example by the occupational health department2
- Petrich J, et al. J Pharm Pract 2020;33(6):846-855.
- Vulto AG, et al. EJHP Pract 2007;13(5):29–39.
- Tisagenlecleucel® [product information]. 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/kymriah-epar-product-information_en.pdf. Accessed 10 March 2021.
- Axicabtagene ciloleucel® [product information]. 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/yescarta-epar-product-information_en.pdf. Accessed 10 March 2021.
- Onasemnogene abeparvovec® [product information]. 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/zolgensma-epar-product-information_en.pdf. Accessed 10 March 2021.
- Voretigene neparvovec® [product information]. 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/luxturna-epar-product-information_en.pdf. Accessed 10 March 2021.