Labelling of Cellular Apheresis and Bone Marrow Products

Blood (apheresis)

A suite of SOPs for adoptive cellular therapy (Immune Effector Cells)

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27/02/2023

Apheresis Training and Competency Manual

Training package to prove nurses with knowledge, skills and expertise to perform specific apheresis procedures for cellular therapy in a safe and professional manner.
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27/02/2023

Apheresis Weekly and Monthly Cleaning Log

A template of an apheresis weekly cleaning log.
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27/02/2023

CAR-T Checklist

Please click here to access CAR-T checklist proforma for admissions and apheresis, with MDT communication sheet.
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21/12/2021

Example SOP: Procurement of Advanced Therapeutic Medicinal Products (ATMPs) – CAR-T cells

Example SOP for the procurement of Advanced Therapeutic Medicincal Products (ATMP) - CAR-T Cells.
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27/02/2023

Nursing Assessment Pre-Apheresis

Nursing assessment form pre-apheresis.
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Online Article
14/07/2022

Procurement of cells or tissues as starting ATMP materials – eLearning Module

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an overview of the procedural requirements for the procurement of human tissues and cells but does not discuss in depth the consent and ethics requirements

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03/08/2020

Receipt processing and release of fresh cells as starting material for manufacture

Form to complete when receiving, processing and releasing fresh cells for manufacturing
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29/04/2021

Recommendations on the procurement of starting materials by apheresis for ATMP manufacture

This guidance document presents a consensus view on standardised approaches to mononuclear cell procurement to reduce unnecessary complexity and variation
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27/02/2023

SOP – Approving apheresis and high risk immune effector cell trials

This SOP aims to ensure that proposed trial protocols, requiring access to Cellular Therapy and Transplant Programme services, are reviewed by the appropriate staff prior to being authorised to open.
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27/02/2023

SOP – Coordinating Adoptive Cellular Therapy

An SOP outlining the procedures for the coordination and delivery of adoptive cellular therapy within The Christie NHS Foundation Trust.
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27/02/2023

SOP – Labelling of Cellular Apheresis and Bone Marrow Products

The objectives of this SOP are to ensure products are correctly and consistently labelled to ensure the positive identification of each harvest and facilitate cell chain to track from donation to reinfusion. For products transferred to areas outside the Clinical Apheresis Unit, and those reinfused within the transplant programme.
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27/02/2023

SOP – Maintaining a safe environment within the clinical apheresis unit

SOP regarding the maintenance of a safe environment in a Clinical Apheresis Unit of an NHS hospital.
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29/03/2022

UK review and recommendations on cryopreservation of starting materials for ATMP

Cryopreservation is now integrated into the manufacturing workflow of approved ATMPs. However, a comprehensive end-to-end solution for large scale ATMP production is still under development. This document provides an overview of the current state of cryopreservation in ATMP workflows by: addressing where cryopreservation fits into the workflow, the rules and regulations, the major challenges of cryopreservation logistics; reviewing the effects of cryopreservation of starting materials on the final product safety and efficacy and how developing technologies are set to help optimize cryopreservation processes for scalable manufacturing.
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30/09/2021

Worklist for Issue of frozen products for as starting material for manufacture

A checklist to follow to confirm all steps are appropriately carried out for cell therapy starting materials to be sent to manufacturer
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  • Governance

    Governance

    Read more about this section.

    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

    Read more about this section.

    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

    Read more about this section.

    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

    Read more about this section.

    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

    Read more about this section.

    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

    Read more about this section.

    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

    Read more about this section.

    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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