Explore the Agenda
8:55 am Chair’s Opening Remarks
Developing Fit-for-Purpose Donor Selection Strategies to Maximize Therapy Performance & Manufacturing Success
9:00 am Establishing Comprehensive Donor Characterization Panels to Predict Manufacturing Performance
- Establishing donor pre-screening assays to characterize donor materials from a molecular, phenotypic and/or functional perspective ahead of full-scale manufacturing
- Leveraging characterization data to accelerate selection of high-performing donor materials for the manufacturing of consistent and high-quality cell therapy products
- Implementing workflows to identify starting material attributes correlating with cell therapy product manufacturability, quality and consistency to minimize manufacturing failures and lot-to-lot variability
9:30 am Ensuring Consistent Donor Material Characterization to Strengthen Clinical-Stage Cell Therapy Development
- Standardizing donor screening criteria to reduce variability and improve starting material consistency across clinical manufacturing campaigns
- Implementing robust donor characterization assays to strengthen comparability between batches and support reliable clinical outcomes
- Establishing fit-for-purpose quality control frameworks to identify variability early and maintain product consistency throughout development
10:00 am Assessing How Storage Temperatures & Delayed Processing of Fresh Leukopaks Impacts Functionality of Immune Cells from Different Donors
- Transit and processing delays for fresh leukopaks as well as donor variability can drastically impact the functionality of the immune cells. Thus, it is crucial to determine the optimal storage and processing conditions to preserve stability of these cells
- In a study conducted by Rose BioSolutions, we examine the effects of delayed fresh leukopak processing, after storage for up to 96-hours at either cold or room temperature, on the stability and functionality of the immune cells isolated from three donors
- We will share impactful data highlighting how storage temperatures and delayed processing of fresh leukopaks coupled with donor variability can impact immune cell viability, cell frequencies, T-cell activation, and NK cell cytotoxicity
10:30 am Morning Refreshment Break & Networking
Strengthening Donor Retention, Re-Engagement & Consent Strategies to Secure Long-Term Cell Source Availability
11:30 am Roundtable Discussion: Improving Donor Recruitment & Retention to Ensure Reliable Access to High- Performing Donors
- Sharing successful donor engagement strategies to improve retention rates and facilitate efficient re-collection when additional manufacturing is required
- Identifying key drivers of donor attrition to develop practical retention programs that increase long-term donor commitment
- Collaborating with apheresis centres, blood banks and donor registries to strengthen recruitment pipelines and expand access to diverse donor populations
12:15 pm Optimizing Donor Consent Frameworks to Enable Compliant & Scalable Microbiome Research Session Highlights
- Implementing dynamic consent models to strengthen donor engagement while supporting long-term microbiome sample utilization
- Harmonizing consent language across collection sites to reduce regulatory risk and improve global study scalability
- Establishing governance processes for secondary sample use to maximize research value while maintaining donor trust
12:45 pm Lunch Break & Networking
Leveraging Donor Selection & Potency Testing Frameworks to Ensure Reliable Cell Therapy Performance
1:45 pm Harnessing Elite Donor Selection Strategies to Enhance HSC-Derived NK Cell Manufacturing Performance
- Identifying high-performing donor characteristics to generate potent, consistent HSCderived NK cell products at scale
- Implementing donor screening and qualification frameworks to improve manufacturing success rates and reduce variability
- Leveraging donor-derived cellular attributes alongside expansion technologies to enhance therapeutic efficacy and commercial readiness
2:15 pm Establishing Robust Potency Assays to Overcome Donor Variability & Deliver Consistent Global Cell Therapy Products
- Qualifying donors, reagents, manufacturing processes and in vitro assays to build FDA-approved potency assays that ensure consistent product release across batches
- Leveraging 10 years of clinical correlations and potency assay development to demonstrate safety, efficacy and reproducible performance independent of donor variability
- Implementing globally reproducible potency testing frameworks to support regulatory approval, commercial scalability and manufacturing consistency across international sites
2:45 pm Afternoon Break & Refreshments
Future-Proofing Cell Sourcing Strategies to Sustain Reliable Supply & Long-Term Therapeutic Success
3:15 pm Roundtable Discussion: Preparing for In Vivo Therapies to Protect Market Position & Adapt Sourcing Strategies for Long-Term Competitiveness
- Examining whether in vivo CAR-T and gene therapy approaches could reduce demand for ex vivo cell manufacturing and donor sourcing infrastructure
- Discussing how the allogeneic cell therapy field should respond to competitive pressure from in vivo modalities to maintain relevance and investment
- Evaluating whether suppliers, CDMOs and technology providers will sustain business models if market demand shifts toward in vivo approaches
4:15 pm Exploring Emerging Cell Sources & Platform Technologies to Expand Sourcing Options & Reduce Supply Constraints
- Evaluating iPSC-derived cell products as alternative sources that enable single-clone, single-donor strategies with unlimited expansion potential
- Assessing cord blood versus PBMC versus bone marrow sourcing trade-offs based on cell content, engraftment kinetics and manufacturing requirements
- Investigating whether iPSC platforms will fundamentally reshape donor selection by shifting focus to optimal source material for iPSC generation
4:45 pm Optimizing Donor Selection Strategies to Enhance Manufacturing Consistency & Cellular Therapy Product Quality
- Evaluating how donor characteristics and collection variables influence starting material quality, manufacturing success rates, and final product consistency
- Assessing Moffitt Cancer Center’s approach to balancing donor availability, cellular attributes, and operational considerations across clinical and commercial programs
- Implementing cross-functional donor selection and manufacturing strategies to reduce process variability, improve scalability, and support more reliable patient outcomes