Procurement of Starting Materials

Information and considerations during the collection of starting materials for the manufacture of advanced therapies can be found here, including model SOPs in relation to:


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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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Apheresis Weekly Cleaning Log

A template of an apheresis weekly cleaning log.
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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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Consenting Hepato-Pancreatico-Biliary (HBP) patients for Bio-bank SOP

SOP re: consenting Hepato-Pancreatico-Biliary (HBP) patients for biobank
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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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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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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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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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Nursing Assessment Pre-Apheresis

Nursing assessment form pre-apheresis.
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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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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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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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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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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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SOP – Tissue Collection from Neuro Patients

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