Advanced Therapies NHS Readiness Toolkit

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.

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an overview of the requirements for labelling human tissues and cells for use as starting materials for advanced therapy medicinal products using the ISBT 128 system.

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.

Form to be completed on the disposal of IMP or ATMP

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

This document can be used to help prompt consideration and recording of the competencies that are needed to work safely with dry shippers and/or dry ice.

Some ATMPs contain living cells. These cell-based therapies may be cryopreserved to extend their shelf life, requiring carefully controlled thawing prior to administration. Failure to thaw the product correctly may impair the integrity of the cells (viability and/or function) and the product may be rendered unfit for purpose. This document describes and example procedure for thawing cryopreserved ATMPs using a water bath.

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

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

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

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.

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 training video demonstrating the thawing of a cryopreserved cell therapy product using a waterbath

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

A training resource on the importance of correctly thawing and inspecting cell therapy medicinal products