Explore the Agenda
8:30 am Check in & Light Breakfast
Workshop A: Improving Flow Cytometry Reliability to Enable Confident QC Release Decisions for Cell Therapies
9:00 am Improving Flow Cytometry Reliability to Enable Confident QC Release Decisions for Cell Therapies
Flow cytometry is widely used in cell therapy development but remains difficult to implement in a QC environment workflow. Variability across reagents, instruments, sample preparation and data analysis creates significant risk without thorough technical knowledge about flow cytometry. At the same time, evolving technologies such as spectral cytometry and shifting regulatory expectations are increasing complexity rather than reducing it, leaving many teams uncertain about how to build robust and future-proof approaches.
This workshop provides a practical forum to explore:
- Identifying and controlling sources of variability across reagents, instruments, sample preparation and data analysis
- Harmonizing instruments, antibody panels and reporting across internal and external partners
- Building standardized and reproducible methods that support regulatory confidence and long-term quality control
Workshop B: Implementing GMP Ready NGS Workflows to Improve Confidence in Complex Gene Therapy Analytics
9:00 am Implementing GMP Ready NGS Workflows to Improve Confidence in Complex Gene Therapy Analytics
As genome-edited and multi-edit therapies become more complex, NGS is emerging as a critical tool for product characterization, genome integrity assessment, and safety evaluation. However, translating these methods into a validated, reproducible GMP environment remains a major challenge. Variability across sample preparation, sequencing platforms, and bioinformatics pipelines creates uncertainty about what is truly being measured, while regulatory expectations for validation are still evolving.
Join this workshop to learn more about:
- Building end to end workflows that control variability from sample preparation through sequencing
- Selecting sequencing approaches that align with analytical goals while managing trade-offs in accuracy and coverage
- Validating bioinformatics pipelines to meet regulatory expectations for reproducibility and data integrity
- Applying NGS to improve understanding of genome integrity and complex product composition
12:00 pm Lunch Break & Networking
Workshop C: Improving Reproducibility in Cell-Based Assays Through Better Control of Cell Inputs & Assay Setup
1:00 pm Improving Reproducibility in Cell-Based Assays Through Better Control of Cell Inputs & Assay Setup
Cell-based assays remain a critical tool for characterizing potency and functional performance, yet variability in assay design, execution, and biological inputs can limit confidence in results. As organizations seek to generate more meaningful and reproducible potency data across development programs, there is increasing need for practical approaches that reduce variability, strengthen assay robustness, and maximize the value of a single functional assay across multiple decision points.
This workshop will gather experts to discuss
- Standardizing assay setup, cell quantification approaches, and acceptance criteria to improve reproducibility of functional readouts
- Optimizing co-culture timing, cell ratios, spheroid formation, and culture conditions to reduce experimental variability
- Establishing robust controls, normalization strategies, and assay performance metrics to increase confidence in data interpretation
- Expanding the utility of potency assays by generating predictive and decision-enabling data across development programs
Workshop D: Enabling Pragmatic Analytical Strategies to Support Gene Therapy Approvals in Today’s Regulatory Environment
1:00 pm Enabling Pragmatic Analytical Strategies to Support Gene Therapy Approvals in Today’s Regulatory Environment
As gene therapy programs advance toward pivotal development and approval, analytical leaders must balance scientific rigor with practical development realities. This workshop will explore how to build fit-for-purpose analytical packages, establish meaningful potency strategies, and generate the evidence needed to support regulatory decision-making while minimizing unnecessary complexity.
This session provides a platform to delve into:
- Identifying the critical assays needed to characterize product quality, support regulatory submissions, and inform development decisions.
- Determining how and when to evolve potency approaches from early development through approval.
- Demonstrating target engagement and biological activity when clinical datasets are limited.
- Developing analytical strategies that support current milestones while reducing rework later in development.