Use of ISBT 128 embedded in the single european code in the contract manufacture of cryopreserved hematopoietic stem cells

Abstract

Background & Aim In the manufacture of cell-based medicinal products and ATMPs, the ISBT 128 Code has proven useful to provide a globally unique identifier and detailed characterization of a product. ISBT 128 coding is used for all products in our facility, a multi-purpose facility for cell-based products including ATMPs. With Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC coming into force, tissue establishments in the EU were obliged to affix a Single European Code (SEC) on tissues and cells distributed for clinical application. The SEC consists of two parts: a donation identification sequence, essentially indicating the origin of the tissue or cells, and a product identification sequence, classifying the type of tissue or cells. While the EU Tissue Code (EUTC) does not allow for a detailed characterization of the cellular product or tissue, the SEC offers the option to accommodate the ISBT 128 Product Description Code. We were contracted to perform the processing and cryopreservation of hematopoietic stem cells (HSC) for clinical use. The Contractor was required to retain his tissue establishment (TE) code on the final product. Labelling was to follow national rules and language. We describe how we integrated the ISBT 128 Product Description Code into the existing process and the SEC as follows. Methods, Results & Conclusion Both components of the SEC, the Donation Identification Sequence and the Product Identification Sequence, are generated at the Apheresis Facility (the Contractor), using the generic EUTC. - Upon receipt, the apheresis product is assigned an ISBT 128 Donation Identification Number for internal documentation, flag labelling, and release documentation, and an ISBT 128 intermediate Product Description Code for further processing. - The finished product is assigned a final ISBT 128 Product Description Code for administration. This code can be embedded in the SEC product identification sequence of the contractor. By doing so, the detailed characteristics are included in the ISBT 128 Product Description Code while retaining the contractor's TE Code and the unique collection identifier. As a next step, translated versions of the SEC/ISBT 128 label will be integrated into the Stemsoft Software labelling functionality (Stemsoft Software, Vancouver BC, Canada). We would like to invite other facilities to make use of this approach and of our documents developed for this purpose. Reference: ST-012 ISBT 128 and the Single European Code (SEC) v1.3.1 ( www.iccbba.org )