Advanced Therapies NHS Readiness Toolkit

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

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.

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

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

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

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

SOP re: consenting Hepato-Pancreatico-Biliary (HBP) patients for biobank

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.

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.

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.

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

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

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

Form to complete when receiving, processing and releasing fresh cells for manufacturing