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Ex-vivo non-GMO gene therapy medicinal products

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Topics: Advanced therapy medicinal productsClinical trialsGuidanceService advice and planning

This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing ex-vivo non-genetically modified organism gene therapies.

About

Scientific advances have introduced innovative medicines using Non-Genetically Modified Organism technologies which are classed as Gene Therapies. Ex-Vivo Non-GMO Gene Therapy Medicinal Products are ATMPs and require Pharmacy oversight even when they are handled by another department within the same organisation or a third party provider. Examples of Ex-Vivo Non-GMO GTMPs include cell based medicines utilising gene editing technologies.

Separate guidance for Ex-Vivo Gene Therapies containing GMOs is available at Ex-vivo GMO gene therapy medicinal products (SPS page).

Purpose

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 Non-Genetically Modified Organism Gene Therapies Medicinal Product (Non-GMO GTMP).

This document presents a flow diagram outlining a stepwise approach for implementation of processes to prepare and administer Non-GMO GTMPs. It is followed by checklists which relate to the various steps required and presented in the diagram.

Attachments

Update history

  1. Title amended.
  1. Minor editorial change on page 3.
  1. Published