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WP2 — Standards of Care

Main aims: 

Develop harmonised guidelines on patient and product management for health care professionals. Reduce inspection burden and redundancies by developing and implementing consensus-driven requirements and qualification standards for clinical teams delivering gene and cellular therapies from cells and tissues of hematopoietic origin.

Current status: 

This work package has various committees working on harmonisation of site qualification standards, apheresis guidelines and pharmacy institutional readiness guidelines for ATMPs.

Committee on harmonisation of site qualification standards works together with HCPs, JACIE and pharma representatives.
The complexities of CAR T-cell therapies and their supply chain require pharmaceutical companies to qualify apheresis and treatment centres. However, with multiple CAR T-cell products on the market and many more in clinical trials, centres are confronted with an increasing inspection workload.

The aim of this group is to evaluate existing site qualification standards, work towards harmonisation by leveraging  existing qualification schemes and ultimately reducing inspection workload on apheresis and treatment centres.

Committee on harmonisation of apheresis procedures for ATMP manufacturing.
This group of international apheresis experts started in December 2021. The point of departure is that the quality and safety of ATMPs is contingent on that of their starting materials, particularly when these are substance of human origin. Harmonisation of apheresis procedures will contribute to quality and safety of the medicinal product, efficiency of the process and a reduction of the risk of error.

The group will build onto the SAMPLE project done by Catapult UK. Catapult UK and their network of network of advanced therapy treatment centres (ATTC)  reviewed apheresis procedures across the UK centres. This resulted in recommendation guidelines on the procurement of starting materials by apheresis for ATMP manufacture. The aim is now to expand the scope from the UK to the wider European setting. 

Committee on guidelines for pharmacists working with ATMPs.
CAR T-cell therapies and other ATMPs are medicinal products and as such fall under the responsibility of pharmacists, even though their storage and handling may require expertise from e.g. stem cell laboratory specialists.
This group of international pharmacists started in December 2021. They will build on

Work done by the Pan-UK Pharmacy Working Group for ATMPs, which developed institutional readiness guidelines for CAR T-cell therapies and four broader classes of ATMPs. The aim is now to expand the scope from the UK to the wider European setting.