Vice President – Clinical and Research Quality Services Vitalant Scottsdale, American Samoa
Proposed Session Description: No standardized guidance exists for donor deferral periods following leukapheresis collections for cellular starting material (CSM) used in commercial cell and gene therapy manufacturing. In its absence, collection facilities have developed varying practices based on limited evidence, plasma collection guidance, or their own experience—creating inconsistency in donor safety, operational planning, and biopharma partner expectations. The AABB Cellular Starting Material and Biotherapies Services Work Group surveyed current practices across facilities performing allogeneic MNC collections for commercial use. This moderated panel discussion will bring together practitioners from multiple collection sites to share findings, explore areas of consensus and variation, and discuss the critical distinctions between suitability screening (donor safety), eligibility screening (regulatory compliance), and customer specifications (manufacturing requirements)—and how each shapes deferral decisions. Panelists will present a proposed framework for evidence-informed deferral periods that balances donor recovery and product quality, followed by robust Q&A.
Learning Objectives:
• Differentiate suitability, eligibility, and customer specification screening in CSM deferral decisions
• Compare current deferral practices across collection facilities performing allogeneic MNC collections
• Bring peer-informed deferral considerations back to their facility to support local practice evaluation and contribute to emerging field guidance
