Day One

• Identifying critical quality attributes in starting material that correlate with expansion rates, cell viability and final product yield to minimize costly manufacturing failures
• Implementing upfront screening assays to characterize donor health status, cellular phenotype and functional markers before committing to full-scale production
• Leveraging characterization data to reduce time spent evaluating unsuitable donors and accelerate selection of high-performing material for consistent output

• Utilizing artificial intelligence and machine learning to analyze donor datasets and identify patterns that predict manufacturing success and therapy efficacy
• Building algorithms that force-rank donor variables and enable rapid decision-making when selecting between multiple candidate sources
• Establishing correlations between laboratory characterization results and clinical outcomes to validate predictive models and refine selection frameworks

The challenge of defining fit-for-purpose donor material cannot be solved in silos. This structured

networking session connects you with fellow attendees for a series of rapid introductions, giving

you the opportunity to exchange ideas, benchmark strategies, and build relationships with the

experts shaping donor sourcing, screening, characterization, and management across allogeneic

cell therapy development.

• Establishing donor qualification and documentation workflows to meeting commercial GMP requirements while reducing regulatory compliance risks
• Implementing chain of identity and custody controls to strengthening donor material traceability across manufacturing operations
• Aligning quality, manufacturing and regulatory oversight to maintaining inspection readiness throughout commercial scale-up activities

• Building strategic relationships with blood banks, apheresis centers and cord blood banks to ensure consistent material availability and quality alignment
• Establishing clear communication of donor requirements, testing specifications and delivery expectations with external partners to prevent misalignment
• Auditing supplier capabilities, quality systems and regulatory compliance to qualify vendors that can support long-term commercial needs

• Understanding current cchain of identity requirements to ensure compliance with evolving FACT-JACIE expectations and industry best practices for donor material traceability
• Implementing the ISBT 128 chain of identity identifier standard to create globally unique identifiers, improve interoperability, and reduce errors across clinical and manufacturing workflows
• Maintaining end-to-end traceability through standardized labeling to strengthen patient safety, support biovigilance investigations, and enable efficient product tracking from donor to patient

• Comparing regional donor eligibility requirements and sourcing frameworks to reduce delays when expanding programs across global markets
• Establishing local donor and raw material supply strategies to mitigate cross-border logistics, tariff and importation constraints
• Designing adaptable manufacturing platforms using region-specific donors and serum to maintain consistent product quality globally

• Identifying donor attributes associated with superior cell fitness to improve clinical efficacy and manufacturing consistency across allogeneic therapies
• Comparing HLA-dependent conventional approaches with MHC-unrestricted γδ T-cell strategies to expand donor accessibility and broaden tumor targeting
• Leveraging donor selection, immune activation and expansion characteristics to overcome tumor evasion mechanisms and enhance therapeutic performance

• Identifying donor-derived risks during manufacturing and testing to reduce late-stage batch failures, resource losses and release delays
• Understanding how unexpected donor characteristics impact product quality to strengthen proactive risk mitigation strategies
• Quantifying the downstream impact of donor variability on patient supply to improve manufacturing robustness and product availability