Quality approaches in cell therapy: patient and therapy‐related aspects

Abstract

Quality requirements for cell therapy programmes are those that involve regulation and licensing operating at a European and National level, for example, the EU Directive on Tissues and Cells, National Tissue Regulations and voluntary accreditation schemes usually associated with international organizations, for example, The Foundation for Accreditation of Cell Therapy–Joint Accreditation Committee of ISCT (Europe) and EBMT (FACT‐JACIE) and the World Marrow Donor Association (WMDA). Important aspects of patient and therapy‐related quality requirements are those for donors, including selection, evaluation and management. WMDA standards apply to unrelated donors, while, for example, in the UK the requirements of FACT‐JACIE and the Competent Authority – the Human Tissue Authority, are essential. Donors must give appropriate consent and be properly evaluated to assess their fitness to donate and to exclude any condition that might harm the recipients of their cells. Testing must include markers of infectious disease , human leucocyte antigen typing and ABO group. A significant proportion of unrelated donor cell therapy products are collected from donors in other countries, including those outside the EU and organizations, such as the Alliance for Harmonization of Cell Therapy Accreditation aim to achieve an international consensus on the requirements for donors and the donation process, working with the European Union authorities and other bodies. Essential aspects of patient quality include definition of a minimum programme size, specifications for in‐ and out‐patient facilities, access to appropriate supportive care, for example, intensive therapy units, provision of cytomegalovirus‐appropriate blood products and access to doctors in radiation oncology, respiratory medicine and other key specialities. The Quality Management Programme is central to every aspect of a cell therapy programme today. Essential features include training programmes, audit, reporting and review of severe adverse events, accidents and complaints. The FACT‐JACIE standards also define the requirements for therapy administration, including radiotherapy, clinical research and data management. The burden of inspection for cell therapy programmes is increasing but with the aim of improving quality and safety.