Advanced Therapies NHS Readiness Toolkit

A proforma for submission to the Manchester Clinical Research Facility (Christie site), which outlines NHS Trust clinical and resource requirements, prior to study set up.

A proforma outlining considerations for an NHS Trust prior to commencing a cell therapy / immune effector cell trial.

A template produced by The Christie NHS Trust to hold and update frequently asked questions and responses to cell therapy trial feasibility questionnaires.

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

A template of an apheresis weekly cleaning log.

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.

Nursing assessment form pre-apheresis.

CAR-T checklist proforma for admissions and apheresis, with MDT communication sheet.

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

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.

SOP to ensure all nursing and medical staff involved in the infusion of cellular products are aware of their responsibilities, the procedure and any action to be taken in the event of adverse reactions or incident.

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

Poster outlining the approach to developing an NIHR Clinical Research Facility which is safe for the delivery of Oncology ATMP trials.

Outline guide for management of inpatients receiving immune effector cells

Policy and guidelines on the management of Cytokine Release Syndrome with cellular therapies (notably CAR-T cells) and bi-specific T cell engaging antibodies (eg blinatumomab).

SOP to outline the framework and key aspects of training for pharmacists practicing within haematopoietic cellular therapies at The Christie NHS Trust.

CAR-T follow up checklist

DLBCL CAR-T follow up checklist.

Template proforma for medical assessment of patients for bone marrow harvest or therapeutic apheresis

SOP for safe discharge and follow-up for patients, post Chimeric Antigen Receptor (CAR) T-cell therapy infusion.

This guidance produced by the Pan UK Pharmacy Working Group for ATMPs describes the legal basis for associated activity and provides guidance for Pharmacy clinical trial sites who may need to outsource these services.  The information provided will guide Pharmacy trial sites in establishing appropriate partnerships and understand the regulatory position with regard to the activities contracted.

Guidance produced by the Pan UK Pharmacy Working Group for ATMPs regarding the operational implications of the UK exit from the EU for NHS Pharmacy clinical trial sites, including ATiMPs

Advice produced by the Pan UK Pharmacy Working Group for ATMPs for Pharmacy sites on costings for clinical trials of ATMPs, using the NIHR interactive costing tool.

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.

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.

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.

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.

This poster presentation is the product of a short live working group of ATMP industry partners and captures the non-label (not appearing on the product label) data produced during an exemplar apheresis process. The poster aims to demonstrate the ability for standardisation of data transfer from NHS to manufacturers.

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 flow diagram showing the pathway a patient follows when receiving a CAR T.

Form to be completed on the disposal of IMP or ATMP

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

A checklist to confirm ATMP is received appropriately from the manufacturer prior to administration to a patient

Checklist to follow on thawing and administering ATMP to patients

An example job description for a senior clinical practice facilitator to help develop the advanced therapies team through education

This paper outlines observations and recommendations on developing the role of pharmacy in delivering ATMPs in NHS Scotland

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

A visual guide to the preparation, administration and disposal of non-cellular, genetically modified organisms (GMOs), in a clinical setting

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

Self-assessment questionnaire to assess regulatory compliance in The Christie Pathology Partnership Laboratories to perform the storage and release of ATMPs

Checklist to be completed on the issue of IMP or ATMP

The training passport is designed for all pharmacists providing pharmaceutical care to HSCT patients including those undergoing autologous and allogeneic transplant, patients admitted to the HSCT unit with post-transplant complications and patients attending post-transplant out-patient clinics

This publication reports on a study to assess institutional readiness (IR) of NHS sites that form part of the Northern Alliance Advanced Therapy Treatment Centre to deliver advanced therapy medicinal products, and discusses the development of an assessment tool to support self-assessment of IR in healthcare institutions

Template form used to review and assess a new ATMP clinical trial

Full job description for a lead clinical trials nurse focussing on advanced therapies

An audit template for the oversight of pharmacy with the stem cell laboratory for the storage and handling of ATMPs

This document sets out an example generic checklist for transfer of shippers containing Advanced Therapy Medicinal Products (ATMPs) to clinical areas, and their return to the sending laboratory.

A flow diagram showing the pathway a patient and treatment would follow for an autologous ATMP to be administered

This document sets out an example generic checklist for receipt and storage of fresh, allogeneic, cellular Advanced Therapy Medicinal Products

This document sets out an example generic checklist for autologous, cryopreserved, cellular Advanced Therapy Medicinal Products (ATMPs)

This document sets out an example generic checklist for allogeneic, cryopreserved, cellular Advanced Therapy Medicinal Products (ATMPs).

A Pan UK Pharmacy Working Group for ATMPs resource.

Some medicines, including many ATMPs, achieve greatest stability at ultra-low temperatures. Therefore the use of -80°C and below is commonplace to achieve optimal product shelf-life. As the usage of ATMPs is increasing, Pharmacy departments are becoming required to receive shipments and to store products at ultra-low temperatures

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

Ex vivo gene therapy medicinal products are ATMPs, which require pharmacy oversight, even when being handled elsewhere within a healthcare organisation. This document produced by the Pan UK Pharmacy Working Group for ATMPs outlines the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any ex vivo (cell based) Gene Therapy Medicinal Product (GTMP)

The purpose of document produced by the Pan UK Pharmacy Working Group for ATMPs is to outline the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any in vivo (virus based) Gene Therapy Medicinal Product (GTMP) e.g. IMP for Clinical Trials or Marketed ATMPs.

The purpose of this document produced by the Pan UK Pharmacy Working Group for ATMPs is to outline the key areas where Chief Pharmacists should focus pharmaceutical expertise prior to an organisation implementing any Somatic Cell Therapy Medicinal Product (sCTMP). This document presents a flow diagram outlining a stepwise approach to implementing processes to prepare and administer sCTMPs. It is followed by checklists which relate to the various steps presented in the diagram

The purpose of this document produced by the Pan UK Pharmacy Working Group for ATMPs is to outline the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any Tissue Engineered Product.

A document summarising the challenges and solutions the the collection of starting materials for ATMP manufacture though apheresis

To describe the procedure for managing CTPs used as ATMP which are manufactured outside The Christie NHS Foundation Trust, received, stored and issued by The Stem Cell Laboratory at The Christie Pathology Partnership which has been prescribed by an appropriate prescriber

Detailed pathway that a patient follows when undergoing adoptive T-cell therapy

A summary of activities across NA-ATTC hospitals geared towards patient centred, safe and efficient trial set-up, delivery and completion

A Pan UK Pharmacy Working Group for ATMPs resource to clarify the regulatory perspective regarding Out of Specification (OOS) ATMPs, and to provide guidance to NHS organisations which are provider sites for ATMPs, about governance in the event of an OOS ATMP being supplied for one of their patients.

The purpose of this guidance produced by the Pan UK Pharmacy Working Group of ATMPs is to outline the responsibilities of pharmacists where preparation of advanced therapy medicinal products (ATMPs) holding marketing authorisations is required prior to administration in hospitals. Full compliance with the summary of product characteristics (SmPC) requirements is always recommended.  This guidance clarifies where activities require the oversight of a pharmacist and distinguishes circumstances in which preparation under the supervision of a pharmacist would be a legal requirement. It provides definitions and distinction between the use of these terms.

A Pharmacy Working Group of ATMPs resource. CAR-T treatments require governance and management by Chief Pharmacists. They present risks which Chief Pharmacists should ensure are minimised. Whilst collaboration with expert cellular product handling colleagues will be key operationally, it may present challenges for Pharmacy to embed this new working relationship

Output of a workshop to address the issues of arrival of ATMPs at a hospital site and the internal logistics (including moving, handling, storage and training) thereafter

A Pharmacy Working Group for ATMPs resource. Pharmacy is often the first port of call when an organisation wishes to use a gene therapy and needs to provide pragmatic guidance to facilitate the introduction of these innovative products. This document is designed to give practical advice to centres wishing to undertake gene therapy trials and need to understand the requirements and recommendations for governance and, in particular to have in place a Genetic Modification Safety Committee. The document also gives practical advice for centres to help them understand operational requirements including deciding the optimal location for preparation.

The Pan UK Pharmacy Working Group (PWG) for ATMPs was established in 2018 to act as an expert and informed body to support the activities of UK Pharmacies to facilitate ATMP usage. This is a link to their homepage on the specialist pharmacy service webiste

This document produced by the Pan UK Pharmacy Working Group of ATMPs describes the role of Pharmacy in overseeing the governance arrangements and ensuring that Advanced Therapy Medicinal Products (ATMPs) used are of the appropriate quality for their intended use.

Job Description detailing the key responsibilities, skills and behaviours applicable for an Aseptics and Cellular Therapies Pharmacist

Developed by the CRUK Manchester Institute, this SOP describes the procedure for performing Quanterix SP-X ELISAs (Formerly known as Aushon Ciraplex and referred to simply as multiplex in this document). (Enzyme Linked ImmunoSorbant Assay) using the Quanterix SP-X imaging system (Formerly known as Aushon Cirascan).

This facilitated workbook has been developed for new and existing staff, caring for patients undergoing IEC therapy, usually within the context of a clinical trial.

A flow chart showing the pathway a patient and treatment would follow for an allogeneic cell therapy to be administered