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.
EBMT launched the GoCART Coalition in 2020 to provide cell and gene therapy stakeholders a platform to share best practices and develop solutions focused on improving the lives of patients receiving gene and cellular therapies. The GoCART Coalition, founded by EHA and EBMT, is a multi-stakeholder coalition of patient representatives, health care professionals, pharmaceutical companies, regulators, and medical organisations collaborating to maximise the potential of cellular therapies manufactured from cells and tissues of hematopoietic origin. The four main pillars of the Coalition are data, standards of care, education and policy and advocacy.
JACIE develops and maintains global standards for the provision of quality medical and laboratory practice in cellular therapy. Based on these standards, JACIE offers accreditation to transplant and cellular therapy programmes in order to encourage health institutions and facilities to establish and maintain quality management systems impacting on all aspects of their activities and to engage in continuous improvement.