A document summarising the challenges and solutions the the collection of starting materials for ATMP manufacture though apheresis.

Ex vivo gene therapy medicinal products are ATMPs which require pharmacy oversight even when being handled elsewhere within a healthcare organisation. This document produced by the Pan UK Pharmacy Working Group for ATMPs outlines 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).

A Pharmacy Working Group for ATMPs resource. Pharmacy is often the first port of call when an organisation wishes to use a gene therapy and needs to provide pragmatic guidance to facilitate the introduction of these innovative products. This document is designed to give practical advice to centres wishing to undertake gene therapy trials and need to understand the requirements and recommendations for governance and in particular to have in place a Genetic Modification Safety Committee. The document also gives practical advice for centres to help them understand operational requirements including deciding the optimal location for preparation.

A flow diagram showing the pathway a patient and treatment would follow for an autologous ATMP to be administered.

A visual guide to the preparation administration and disposal of non-cellular genetically modified organisms (GMOs) in a clinical setting.

A flow diagram showing the pathway a patient follows when receiving a CAR T.

A Pharmacy Working Group of ATMPs resource. CAR-T treatments require governance and management by Chief Pharmacists. They present risks which Chief Pharmacists should ensure are minimised. Whilst collaboration with expert cellular product handling colleagues will be key operationally it may present challenges for Pharmacy to embed this new working relationship.

This guidance document presents a consensus view on standardised approaches to mononuclear cell procurement to reduce unnecessary complexity and variation.