Abstract 3: Adapting to Evolving Demands: Diversifying Cord Blood Processing to Mitigate Supply Chain and Vendor Risks

Abstract Introduction The shifting landscape of cord blood utilization, with decreasing demand for clinical applications and a rapidly expanding need for cellular therapies, is driving changes in processing practices. However, the industry's continued reliance on single-vendor systems (SVS) for processing poses significant risks. Stringent FDA validation requirements, coupled with increasing vulnerability to supply chain disruptions and the potential for discontinued vendor support, can result in costly and irreplaceable losses of cord blood units (CBU). These losses not only have financial implications but can also delay or prevent life-saving treatments for patients in need. To optimize this valuable resource, a strategic balance between clinical and therapeutic needs is essential. This study investigates the hidden costs associated with SVS reliance and explores the potential benefits of maintaining secondary processing capabilities as a risk mitigation strategy, ensuring the availability of CBU for both current and future therapeutic applications. Objectives This study analyzes the experiences of a FACT accredited public cord blood bank in the USA to: -Highlight the challenges associated with onboarding and validating a new SVS for CBU processing. -Quantify the CBU losses resulting from validation, supply chain disruptions, and instrument downtime. -Demonstrate the long-term cost-effectiveness of maintaining secondary processing capabilities to mitigate such losses. Methods A retrospective review of cord blood processing techniques and product disposition from February 2020 to February 2024 was conducted. Data analysis was performed using SAS JMP Pro 17.0. Results While SVS initially offer lower startup costs, the long-term risks outweigh these savings. CBU losses due to supply chain issues and the need to validate alternative kits can be financially significant. Implementing a secondary, manual processing and by leveraging existing resources increases the total cost by 2%. Discussion The traditional model of relying solely on SVS for CBU processing is unsustainable in the face of modern challenges. This study provides compelling evidence for the cost-effectiveness and risk mitigation potential of maintaining a diversified processing approach. By investing in secondary processing capabilities, cord blood banks can ensure the continued availability of this vital resource for patient transplantation and other cellular therapies, even in the face of supply chain disruptions and vendor changes.