Advanced therapy medicinal products

Topics: Advanced therapy medicinal products

Advice, guidance and individual details for specific advanced therapy medicinal products.

Advice and guidance

Tissue engineered products

This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing tissue engineered products.

Exagamglogene autotemcel (Casgevy®)

This document highlights key areas where Chief Pharmacists should focus pharmaceutical expertise prior to implementation of exagamglogene autotemcel.

In-vivo GMO gene therapy medicinal products

This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing in-vivo genetically modified organism (GMO) gene therapy.

Ex-vivo GMO gene therapy medicinal products

This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing ex-vivo genetically modified organism (GMO) gene therapy.

Ex-vivo non-GMO gene therapy medicinal products

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

Marketed CAR-T therapy

This document outlines key areas where Chief Pharmacists should focus pharmaceutical expertise prior to an organisation implementing CAR-T therapy.

In-vivo non-GMO gene therapy medicinal products

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

Somatic cell therapy medicinal products

This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing somatic cell therapy product.

Outsourcing marketed ATMPs: A template technical agreement

A template Quality Technical Agreement for outsourcing the receipt, storage, preparation and onward supply of marketed cryopreserved ATMPs.

Supportive medicines guidance for adults on CAR-T cell therapy

This document provides expert clinical pharmacy guidance on supportive medicines in order to facilitate the treatment of complex CAR-T Cell Therapy patients.