There are circumstances in collecting and processing cellular therapy products for further manufacture where more than one donation may need to be collected to deliver a given therapy. A new ISBT 128 Standard for the Chain of Identity (CoI) Identifier, developed based on requirements developed collaboratively with the Standards Coordinating Body, was published in December 2022. This new ISBT 128 data structure provides a standardized, globally unique identifier that can be used to link these donations together. This session will describe the hybrid (split) label format for labeling collection products for cell therapy manufacturing, the structure of the ISBT 128 Chain of Identity Identifier, the maintenance of the chain of custody, and how to become a CoI Identifier issuer. The session will also leverage experience from a cell therapy manufacturer’s journey to establish a chain of identity identifier and overcome bottlenecks in implementing strategies to maintain the chain of custody. An interactive discussion will delve into establishing an agreement between the entities involved in the collection for a given therapy regarding the scope of the therapy to be associated with a CoI Identifier and defining who is responsible for allocating the CoI Identifier that will be used throughout the lifecycle of the biological material, and when the CoI Identifier will be allocated.
This session will be presented by the FDA’s Office of Regulatory Affairs (ORA), Office of Biological Products Operations (OBPO). The discussion will include the organizational structure of OBPO, including OBPO’s role in regulatory inspections and current regulatory oversight. The top regulatory violations that are most cited, compliance trends, and actions for biological products, including blood, blood components, and cellular therapies, will be discussed.
Hyperhemolysis syndrome (HHS) is an uncommon but life-threatening complication of transfusion that classically occurs in patients with sickle cell anemia but may also be seen in patients without hemoglobinopathies. Recognition of HHS is critical for appropriate management but can be challenging. The first speaker of this session—a transfusion medicine specialist—will present a systematic review of published HHS cases, articulating the epidemiological, clinical, and laboratory features of HHS and patient outcomes, including in obstetric patients. While evidence-based guidelines for managing HHS are lacking, varied and emerging strategies have been described, such as corticosteroids, intravenous immune globulin, eculizumab, and tocilizumab. The second speaker of this session—a pediatric hematologist-oncologist and transfusion medicine specialist—will present the proposed pathophysiological mechanisms of HHS and an appraisal of current management strategies.
The Tibor Greenwalt Memorial Award & Lectureship honors Tibor Greenwalt, MD, who was the first registrant at the first AABB Annual Meeting and founding editor of TRANSFUSION. The award recognizes an individual who made major scientific or clinical contributions to hematology, transfusion medicine or biotherapies and succinctly communicated these advances. The 2023 Tibor Greenwalt Memorial Award will be presented to D. Robert Sutherland, BSc, MSc .
In the past few decades, blood group genotyping has greatly expanded our knowledge of the more prevalent alleles, paving the way for commercial genotyping assays. These assays have improved efficiency in providing genomic results, but understanding assay limitations can help direct additional investigations for complex cases.Variant alleles may affect protein expression and can be associated with alloimmunization risk after exposure through transfusion, pregnancy, or transplant. While genomic testing has increased understanding of altered antigens, alloimmunization risk remains unknown for many antigens encoded by variant alleles. Bioinformatic tools, including 3D protein modeling, can help assess the impact of amino acid changes encoded by variant alleles and provide insight into alloimmunization risk. When a variant allele is identified, blood bankers and clinicians must understand its clinical impact. In this program, we will review variant alleles, how we detect them, and the difficulty of predicting the risk of alloimmunization. We’ll propose using bioinformatics to gain insight into antigen expression in these cases.
Oral abstract session featuring the latest research on Blood Donor
Plasma and platelet transfusions are frequently prescribed to critically ill children who are actively bleeding or at risk of bleeding. Despite the therapeutic benefits, both plasma and platelet transfusions have been independently associated with morbidity and mortality. Guidelines must be available to help physicians weigh the risks and benefits to pediatric patients. The Transfusion and Anemia eXpert Initiative – Control/Avoidance of Bleeding (TAXI-CAB), in collaboration with the Pediatric Critical Care Blood Research Network (BloodNet) and several other blood transfusion professional organization stakeholders, created a comprehensive series of consensus statements and suggestions for future research foci in the area of plasma and platelet transfusions for critically ill children. TAXI-CAB seeks to provide evidence-based guidance to encourage the use of plasma and platelet transfusions in the right scenarios to maximize their clinical benefit and minimize harm.
This program encompasses the different perspectives from two facilities (an institution that provides GMP laboratory and manufacturing services to multiple sponsors and researchers and an academic hospital-based processing laboratory). Release testing before distribution is an important requirement ensuring patients' safety treated with cellular tissue-based products. The quality and value of these tests can be affected by many factors, including validation of tests and staff training and proficiency. Description of tests and quality control required before release and distribution either for further manufacturing or as a final (finished) product for the administration of human cellular tissue-based products (HCTPs), both minimally manipulated and more than minimal manipulation (361 and 351 type products) will be discussed in this session.
Platelet transfusion refractoriness can be challenging to manage. There is no simple “One Solution” that solves all in platelet refractoriness management. Platelet transfusion has been a mainstay of treatment for patients who become thrombocytopenic due to cancer, malignant hematological disease, and hematopoietic stem cell transplant. However, patients who receive multiple units may develop platelet refractoriness in 15-25% of cases. The more units these patients receive, the more likely they are to receive multiple antibodies, which makes finding the next match more difficult. Patients with high HLA antibodies and a high calculated panel reactive antibody (cPRA) may face long delays in acquiring adequate units, increasing the risk of severe hemorrhage. In this session, we will discuss a variety of treatments for patients who become increasingly alloimmunized and refractory to treatment. We will first discuss the available testing options for performing crossmatching and detecting HLA/HPA antibodies. We will then discuss the progression of transfusion components available from “Good Response” donors, and platelet crossmatches to HLA-compatible and HLA-matched platelets. Finally, we will discuss more novel options for the highly immunized patient, including twenty-four-hour continuous random platelet transfusion, vincristine-infused platelets, Eculizumab therapy, and novel neonatal Fc receptor blockers (Efgartigimod and Rozanolixizumab).