About
Exagamglogene Autotemcel is the UK’s first gene edited medicine to gain a marketing authorisation. It is an ex-vivo gene therapy but it does not contain a genetically modified organism (non-GMO) as it is manufactured using an innovative gene editing technique.
The Pan UK Pharmacy Working Group for ATMPs has produced this dedicated Pharmacy Institutional Readiness guidance in recognition of this classification.
As an ex-vivo gene therapy, Exagamglogene Autotemcel requires pharmacy oversight, even when handling occurs elsewhere within the healthcare organisation or is outsourced.
Purpose
This guidance outlines key areas which chief pharmacists should include within their local systems. It aims to aid consistent and optimal implementation of Exagamglogene Autotemcel.
In line with the SmPC, out pharmacy institutional readiness guidance provides a practical process flow diagram covering governance, operational and some clinical recommendations to enable a stepwise approach to implementation. It is followed by useful checklists relating to steps in the diagram.
Instructions for Use
As part of the your local governance process, in line with PAN-UK-PWG-for-ATMPs-Gene-Therapy-Guidance-V3.pdf (sps.nhs.uk), processes should be defined and risk assessed prior to implementation.
If your organisation wishes to implement Exagamglogene Autotemcel, it is recommended that local systems are documented and that they include all the factors in the guidance below and incorporate actions recommended in the checklists. An editable version has been included to facilitate this.