Cell Manufacture

Cell Manufacture

Back to all overview
PDF
31.03.2022

Evaluation of Sporicidal Surface Sanitisation

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)

Open PDF
PDF
31.03.2022

Identifying barriers to fully enclosed production/common manufacturing approaches for exemplar ATMP

An evaluation of the risks, benefits and opportunities of using closed systems in the manufacture of ATMPs
Open PDF
External link
03.03.2022

Industry/researcher-facing NHS document describing ‘Product Design Considerations for Optimising ATMP Implementation in the NHS’

A guidance document providing practical advice for the development of Advanced Therapy Medicinal Products (ATMPs) to ensure their suitability for NHS implementation.
Go to link
PDF
03.03.2022

MW-ATTC Manufacturing Product Template

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.
Open PDF
PDF
03.03.2022

Possible Pathways from Translational Research to Industrialisation

This document describes the different stages involved in product development from bench to bedside
Open PDF
PDF
03.03.2022

Q&A document examining areas of debate in functional closure

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

Open PDF
PDF
03.03.2022

Receipt and dispatch of apheresis product, and receipt of a CAR-T product at Newcastle Hospitals

Process flow diagrams illustrating the journey of starting material to a CAR-T product in Newcastle Hospitals
Open PDF
PDF
03.03.2022

Vein to vein process for CAR-T cell therapy at NHSBT

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