Advanced Therapies NHS Readiness Toolkit

A standard operating procedure detailing the ‘best practice’ method to check the integrity of the filters in a CliniMACS Prodigy Tubing Set

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)

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

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

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

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.