Collection of Tissues for Isolation of Tumour Infiltrating Lymphocytes – A Process Overview of SOPs

Solid Tumours

A suite of SOPs by cancer type relating to sample collection for isolation of tumour-infiltrating lymphocytes (TILs)

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31/05/2022

Collection of Tissues for Isolation of Tumour Infiltrating Lymphocytes – A Process Overview of SOPs

An overview of points to consider and SOPs required when establishing a new pathway for the collection of tissues to isolate tumour infiltrating lymphocytes (TIL). Relevant for both research and clinical tissue collection.
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31/05/2022

Consenting Hepato-Pancreatico-Biliary (HBP) patients for Bio-bank SOP

SOP re: consenting Hepato-Pancreatico-Biliary (HBP) patients for biobank
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31/05/2022

iMATCH Bio-banking Consent SOP

The process for consenting patient’s tissue to be stored in a biobank for use in medical research, relating to tumour infiltrating lymphocytes (TIL)
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31/05/2022

iMATCH Clinical SOP Development

An overview of patient pathways relating to the collection of tissues to isolate tumour infiltrating lymphocytes (TIL).
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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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31/05/2022

SOP – Overview of Services in Greater Manchester

An overview of surgical sites and services in Greater Manchester, relating to the collection of tissues to isolate tumour infiltrating lymphocytes (TIL).
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31/05/2022

SOP – Preparation and maintenance of tumour-infiltrating lymphocyte, cancer associated fibroblast and autologous tumour cultures (ovarian cancer)

The purpose of this document is to provide clear guidance on the procedures to be followed during the processing of ovarian tumour tissue to establish a) a tumour infiltrating lymphocyte culture; (b) an autologous tumour cell culture; (c) a cryopreserved aliquot of tumour culture digest; (d) subsequent cryopreservation of TIL and autologous tumour cultures for future assays.
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18/01/2022

SOP – Tissue Collection from Neuro Patients

SOP re: tissue consent for Neurological patients relating to TIL therapy research/ treatment.
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31/05/2022

SOP for patient recruitment for Breast Cancer tumour samples for adoptive T-Cell therapy

This SOP will describe the patient recruitment process for prospective breast tumour sample collection (for medical research relating to adoptive T-Cell Therapy)
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18/01/2022

SOP- Generalised Tissue Collection where tissue microarchitecture must be preserved to protect the standard of care

This SOP provides clear guidance on the procedures to be followed during the acquisition of tissue for therapeutic purposes undertaken within the institute/trust.
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31/05/2022

SOP- Generalised Tissue Collection where tissue, surplus to requirement, is available and be collected without effecting standard of care

This SOP provides the basis for the standardised collection of solid tumour and fluid samples from cancer patients undergoing surgical treatment, where there is excessive tumour tissue available which can be collected without effecting the normal standard of care.
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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

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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

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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

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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

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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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    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

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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

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    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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