Advanced Therapies NHS Readiness Toolkit

An evaluation of current guidelines and current technologies used to assess the safety, efficacy and potency of Advanced Therapies

An evaluation of the risks, benefits and opportunities of using closed systems in the manufacture of ATMPs

This document summarises results from the safety testing conducted by Alcyomics of two of the exemplar products; tolerogenic dendritic cells and Anti-SARS-Cov-2 T cell product. A full report is expected to be published later on in 2022 in formal journal.

An experimental report validating the use of sporicidal disinfectant wipes used on blood collection bags to evaluate if leaching occurs (specifically hypochlorous acid and chlorine dioxide)

A guidance document providing practical advice for the development of Advanced Therapy Medicinal Products (ATMPs) to ensure their suitability for NHS implementation.

A British Pharmacopeia whitepaper for the application of flow cytometry for the cell and gene therapy community

A FAQ document exploring the areas of controversy in the manufacture of ATMPs with agreed common solutions and best practice

Process Flow Diagram demonstrating the vein to vein journey for CAR-T cell therapy at NHSBT

Process flow diagrams illustrating the journey of starting material to a CAR-T product in Newcastle Hospitals

This document describes the different stages involved in product development from bench to bedside

This is a template for a new product introduction process –  the process stretching from first discovery to market launch and covers developing, testing and manufacturing a new product.

An FAQ document describing the regulatory and Qualified Person requirements for the ATMP Product Journey

This paper highlights the major themes found in designing and applying flow cytometric analysis for cellular therapies and discusses practical solutions to common problems

Guidance produced by the Pan UK Pharmacy Working Group for ATMPs, providing definitions of oversight and supervision and clarifies where each are required when implementing Advanced Therapy Medicinal Products

A guidance document providing practical advice for centres implementing Gene Therapies detailing Genetic Modification Safety Committees (GMSC), Governance requirements and optimal preparation location

A guidance document detailing the minimum requirements to achieve best practice for Transfer Disinfection in a Pharmacy