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Advanced therapy medicinal products

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Somatic Cell Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance

25 March 2025This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing Somatic Cell Therapy Product.

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

20 March 2025This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing Ex-Vivo genetically modified organism (GMO) Gene Therapy.

In-Vivo GMO Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance

20 March 2025This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing In-Vivo Genetically Modified Organism (GMO) Gene Therapy.

How to undertake an audit of a cell therapy laboratory

18 February 2025A guide to performing audits of cell therapy laboratories where receipt, storage and handling of cell-based ATMPs has been outsourced by the Pharmacy department

Pharmacy Institutional Readiness for Exagamglogene Autotemcel (Casgevy®)

23 August 2024This document highlights key areas where Chief Pharmacists should focus pharmaceutical expertise prior to implementation of Exagamglogene Autotemcel.

How to perform preparation risk assessments for ATMPs

10 April 2024Preparation risk assessment tools for cell and tissue-based Advanced Therapy Medicinal Products (ATMPs) and in-vivo Gene Therapies.

Outsourcing ATIMP Handling: A Template Technical Agreement

7 February 2024A Template Technical Agreement for outsourcing the Receipt, Storage, Preparation and Onward Supply of ATIMPs for Clinical Trial Sites

Requirements for Governance and Preparation of Gene Therapy

6 February 2024Practical advice for centres implementing Gene Therapies detailing Governance requirements and optimal preparation location decision making support.

Horizon scanning for ATMPs

13 June 2023Describes what horizon scanning is, how it is performed for the NHS and it's importance for ATMPs.

Pharmacy Manual Checklist for Clinical Trials for ATIMPs

2 March 2023Pharmacy Manual content expectations for optimal site implementation of ATIMP Clinical Trials.