Manufacturing and Preparation Toolkit

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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Online Article
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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Online Article
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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Online Article
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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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)

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Online Article
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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Online Article
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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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
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Online Article
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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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.
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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
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pdf
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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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

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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
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pdf
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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Explore all toolkit sections

  • Governance

    Governance

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    This section is intended to assist NHS organisations to create or modify governance structures to permit the introduction of advanced therapies, encompassing all levels of governance responsibilities and reporting within hospitals.

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  • Business and financial planning

    Business and financial planning

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    The introduction of advanced therapies into hospital treatment pathways requires a significant financial investment in resources and facilities. Information available here will help organisations to develop the appropriate business and financial plans as they prepare to deliver advanced therapies.

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  • Quality assurance and risk management

    Quality assurance and risk management

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    This section provides examples of, and guidance on, the implementation of quality systems and risk assessments for safe delivery of advanced therapies towards preparing for regulatory inspections.

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  • Operational delivery

    Operational delivery

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    The documents in this section will assist in the implementation of new advanced therapy services in a clinical setting, supporting the transition of guidance into practice.  Documents include process and patient flow charts to map the treatment pathway and information on the in-hospital logistics requirements.

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  • Clinical practice

    Clinical practice

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    Information is available here to support the clinical practice of the delivery of advanced therapies to patients, including patient assessment, handling advanced therapies, product administration, infusion, treatment and monitoring and recording treatment and side-effects.

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  • Education and training resources

    Education and training resources

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    To safely deliver advanced therapies to patients, staff need to be trained in this new modality of therapeutic intervention. This section includes resources that enable staff to learn more about ATMPs including e-learning, facilitating face to face training and competency assessments, and materials to support patient education.

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  • Long term follow up

    Long term follow up

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    A regulatory feature of advanced therapies is the need for longer-term follow up than for other therapeutic modalities.  The information provided here speaks to the methods of data collection for extended follow up patients after treatment.

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  • Clinical trials

    Clinical trials

    Read more about this section.

    This section has a range of resources – split into 8 sub-sections – which will assist NHS sites to prepare for the set up and delivery of advanced therapy clinical trials. Its objective is to disseminate learnings from the ATTCs regarding the governance, infrastructure and processes which underpin successful trial set up and delivery.

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