The quality and safety of Advanced Therapy Medicinal Products (ATMPs) is contingent on that of their starting materials, particularly where these are substance of human origin such as mononuclear cells (MNCs) procured by apheresis. Across the UK there are over 50 Clinical Apheresis Units (CAUs) operating under a Human Tissue Authority (HTA) collecting starting material for ATMPs.
The SAMPLE project brought together experts from NHS CAUs and processing facilities, ATMP and equipment manufacturers, and regulatory and accreditation bodies to agree a set of standard approaches to MNC collection, processing and storage, labelling and traceability, transport and logistics, quality management, audit and regulatory compliance. The field continues to evolve rapidly both nationally and internationally and these recommendations are likely to require continued update in the future.
The document can be found as a part of the NHS readiness toolkit, as this forms a key element of the ATTC support to the NHS in the rapid adoption of ATMPs
The recommendations on the procurement of starting materials by apheresis for ATMP manufacture can be accessed directly here