Manufacturing and Preparation Toolkit

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31.03.2022

Assessing the safety and Graft versus Host Disease (GvHD) reactivity 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.
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01.07.2015

Best Practice re: Transfer of Disinfection in Pharmacy

A guidance document detailing the minimum requirements to achieve best practice for Transfer Disinfection in a Pharmacy
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03.03.2022

British Pharmacopeia MHRA White paper detailing the Flow Cytometry framework for ‘Good Practice’

A British Pharmacopeia whitepaper for the application of flow cytometry for the cell and gene therapy community
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26.01.2021

Cell and Gene Therapy Insights Paper on Best Practice in Flow Cytometry

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

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01.09.2019

Gene Therapy Medicinal Products – Governance and Preparation Requirements

A guidance document providing practical advice for centres implementing Gene Therapies detailing Genetic Modification Safety Committees (GMSC), Governance requirements and optimal preparation location
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01.01.2020

Guidance on Pharmacy oversight and Pharmacist Supervision of licensed ATMPs requiring a preparation/reconstitution step

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
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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
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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.
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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.
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03.03.2022

Possible Pathways from Translational Research to Industrialisation

This document describes the different stages involved in product development from bench to bedside
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01.10.2021

Q&A document about the role of a QP within Advanced Therapies

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

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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
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19.09.2022

Report on the Current Guidelines Regarding Advanced Cell Therapy Safety, Efficacy and Potency Testing

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