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.
The cellular therapy and transplant programme modified existing and created a number of documents in order to deliver advanced therapies and comply with JACIE’s immune effector cell standards (edition 6.01)
E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an introduction to the challenges posed when moving advanced therapies around a hospital and how effective teamwork is required
This document 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
The use of immune effector cell therapies can result in significant toxicities that are directly associated with powerful immune-mediated responses. The most frequently observed of these is cytokine release syndrome (CRS). CRS represents a life-threatening situation that requires early recognition of symptoms and signs and prompt intervention. This short training video can be used to support healthcare professionals and others to gain an introduction to CRS presentation, diagnosis and clinical management.
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