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Reduced CART site qualification workload for JACIE accredited centres

by
JACIE Committee
Inspector Committee
Accreditation Committee
GoCART Coalition

The GoCART Coalition has announced a new initiative to allow apheresis and cell therapy treatment centres accredited by the Joint Accreditation Committee (JACIE) to leverage their accreditation as part of site qualification processes for several global cell therapy manufacturers. Subject to marketing authorisation holders agreement and obligations, centres holding JACIE accreditation will have the option of undergoing a reduced or remote audit focused on product-specific requirements for cell therapies. The GoCART Coalition work group includes JACIE experts, plus industry members Bristol Myers Squibb, Janssen, Kite and Novartis. 

As the number of cell therapies in haematological malignancies continues to grow, treatment centres are confronted with an increasing inspection workload. Manufacturers of cell therapies need to qualify apheresis and treatment centres for the supply of cellular starting materials, the handling of final products for infusion and management of potential adverse events. The Foundation for the Accreditation of Cell Therapy (FACT)-JACIE standards were evaluated against the company requirements for centre qualification, and substantial overlap was found. It was acknowledged that a JACIE accreditation forms a good basis for the qualification of CAR-T cell therapy centres and should be leveraged during site qualification.

Lynn Manson, Chair of the JACIE accreditation committee, said: “JACIE is delighted to receive this acknowledgement of the value of the FACT-JACIE Standards and the JACIE accreditation process from industry colleagues. JACIE looks forward to continuing to work with pharma and biotech companies through the GoCART Coalition to deliver continuous improvements and harmonisation, ultimately to support delivery of the highest quality of care to patients.”
The work toward harmonisation was instituted by a GoCART work group comprising CAR T-cell therapy industry representatives, researchers, clinicians, nurses and JACIE colleagues. The aim of the group is to reduce the inspection workload for centres while not compromising on product quality and patient safety.