Manufacturing and Preparation Toolkit

The Manufacturing and Preparation Toolkit is a compendium of documents detailing best practice and expert guidelines in relation to the manufacture of Advanced Therapy Medicinal Products (ATMPs). The purpose of the Toolkit is to disseminate learnings from the ATTCs and increase awareness of Good Manufacturing Practice for ATMPs.

To assist the reader, Toolkit guidance has been categorised into three areas; Cell Analysis, Cell Manufacture and Pharmacy & Regulatory.

Expand the contents lists below to view an introduction to each section, as well as an outline of the full information contained in the guide.

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Cell Analysis
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Cell and Gene Therapy Insights Paper on Best Practice in Flow Cytometry
26/01/2021 · EXTERNAL LINK
This paper highlights the major themes found in designing and applying flow cytometric analysis for cellular therapies and discusses practical solutions to common problems
British Pharmacopeia MHRA White paper detailing the Flow Cytometry framework for ‘Good Practice’
03/03/2022 · EXTERNAL LINK
A British Pharmacopeia whitepaper for the application of flow cytometry for the cell and gene therapy community
Assessing the safety and Graft versus Host Disease (GvHD) reactivity of ATMPs
31/03/2022 · PDF
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.
Cell Manufacture
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CliniMACS Prodigy™ – Tubing sets and Sterile Filter Integrity Regulatory Guidelines
26/05/2022 · PDF
A standard operating procedure detailing the ‘best practice’ method to check the integrity of the filters in a CliniMACS Prodigy Tubing Set
MW-ATTC Manufacturing Product Template
03/03/2022 · PDF
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.
Possible Pathways from Translational Research to Industrialisation
03/03/2022 · PDF
This document describes the different stages involved in product development from bench to bedside
Industry/researcher-facing NHS document describing ‘Product Design Considerations for Optimising ATMP Implementation in the NHS’
03/03/2022 · EXTERNAL LINK
A guidance document providing practical advice for the development of Advanced Therapy Medicinal Products (ATMPs) to ensure their suitability for NHS implementation.
Receipt and dispatch of apheresis product, and receipt of a CAR-T product at Newcastle Hospitals
03/03/2022 · PDF
Process flow diagrams illustrating the journey of starting material to a CAR-T product in Newcastle Hospitals
Vein to vein process for CAR-T cell therapy at NHSBT
03/03/2022 · PDF
Process Flow Diagram demonstrating the vein to vein journey for CAR-T cell therapy at NHSBT
Identifying barriers to fully enclosed production/common manufacturing approaches for exemplar ATMP
31/03/2022 · PDF
An evaluation of the risks, benefits and opportunities of using closed systems in the manufacture of ATMPs
Q&A document examining areas of debate in functional closure
03/03/2022 · PDF
A FAQ document exploring the areas of controversy in the manufacture of ATMPs with agreed common solutions and best practice
Evaluation of Sporicidal Surface Sanitisation
31/03/2022 · PDF
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)
Pharmacy and Regulatory
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Q&A document about the role of a QP within Advanced Therapies
01/10/2021 · PDF
An FAQ document describing the regulatory and Qualified Person requirements for the ATMP Product Journey
Report on the Current Guidelines Regarding Advanced Cell Therapy Safety, Efficacy and Potency Testing
19/09/2022 · PDF
An evaluation of current guidelines and current technologies used to assess the safety, efficacy and potency of Advanced Therapies
Gene Therapy Medicinal Products – Governance and Preparation Requirements
01/09/2019 · EXTERNAL LINK
A guidance document providing practical advice for centres implementing Gene Therapies detailing Genetic Modification Safety Committees (GMSC), Governance requirements and optimal preparation location
Guidance on Pharmacy oversight and Pharmacist Supervision of licensed ATMPs requiring a preparation/reconstitution step
01/01/2020 · EXTERNAL LINK
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
Best Practice re: Transfer of Disinfection in Pharmacy
01/07/2015 · EXTERNAL LINK
A guidance document detailing the minimum requirements to achieve best practice for Transfer Disinfection in a Pharmacy