Ex-Vivo (cell based) Gene Therapy Medicinal Products – Pharmacy Institutional Readiness Guidance

Ex-vivo gene therapy medicinal products are ATMPs, which require pharmacy oversight, even when being handled elsewhere within a healthcare organisation.

The purpose of this document is to outline the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any ex-vivo (cell based) Gene Therapy Medicinal Product (GTMP).

This document presents a flow diagram outlining a stepwise approach to implementing processes to prepare and administer ex-vivo (cell based) GTMP. It is followed by checklists which relate to the various steps presented in the diagram