Day Two Agenda
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8:00 am Chair’s Opening Remarks
8:15 am Working Smarter Not Harder a Platform Approach to Streamline Development of UCART Cell-Based Gene Therapy
Synopsis
- A platform approach increases flexibility of the analytical toolbox in a fast-paced environment.
- Designing phase appropriate platform assays supports product characterization and development across programs.
- Caveats and pitfalls of the platform approach.
8:45 am Using Advanced Analytics for Cell & Gene Therapy Process Development and Manufacturing
Synopsis
- The value of real-time non-invasive and non-perturbing approaches for assessment of cellular therapies
- Key measurements beyond cell viability and cell count informing cell therapy design, development and manufacturing
- Incorporation of key analytics for in-process measurement of cells throughout the value chain of cell therapy development
9:15 am Interactive Roundtable: Strategies for Analytical Measurement of Potency Assays: Building ATMP Productivity
Synopsis
- Determining critical quality attributes (CQA)
- Measurement procedures and quality control (QC)
- Defining best practice guidelines specific for ATMP characterization and analysis
10:15 am Morning Break
10:58 am
Track A: Immunophenotype Assays
10:59 am Managing Multi-Color Immunoassays to Refine Your Product Development
11:00 am Using Immunoassays to Characterize CAR-T Quality and Donor Cell Variability
Synopsis
- Harnessing immunophenotyping to develop CAR-T products
- Using flow assays to assess quality of CAR-T products
- Leveraging MSD to fully characterize CAR-T products
11:30 am Flow Cytometry-Based Analysis of Genomic Copy Numbers Cells and Nanometer-Sized Particles
Synopsis
- Genomic vector copy number (VCN) reporter cell lines
- Analysis of Exosomes and Lentiviral particles using flow cytometry
- NIST Flow Cytometry Standards Consortium
12:00 pm A Statistical Approach to Robust Design of Cell-Based Assays
Synopsis
- Demonstrate utility of resampling methods in estimating assay variability for laborious cell-based assays
- Assess impact of biological variability on assay outcome
- Balancing clinical and quality considerations to finalize design of potency assay
10:58 am
Track B: Molecular Assays
10:59 am Exploring Vector Characterization to Advance Safety in Analytical Development for Cell Therapies
11:00 am Providing a Holistic View of Vector Testing and Characterization for Manufacturing of Genetically Modified T-Cells
Synopsis
- Leveraging molecular tools for vector characterization
- Determining optimal vector dose with the goal to balance potential safety risks and anti-tumor activity
- Planning batch comparability and scale-up for late-stage development
11:30 am Early-Stage Molecular Assay Development for Characterization of Gene-Edited iPSC Banks
Synopsis
- Exploring the strategies to develop and optimise reliable ddPCR assay(s) for characterizing gene-edited iPSC
- Sharing the experience for selecting molecular assays at early stage of iPSC banks development
- Addressing method optimization to minimize introduction of artifacts during iPSC sample testing
12:00 pm Tools to Assess Purity of Viral Vectors Used for Cell & Gene Therapy Applications
Synopsis
- Discussing residual impurities present in Viral vector materials.
- Exploring analytical assays to Quantitate Residual BSA and HCP in viral vector materials.
- Benchmarking quantitation of Residual BSA and HCP in Viral vector materials
10:58 am
Track C: Cell-Based Assays
10:59 am Overcoming Heterogeneity for Robust Cell Based Assays to Improve Confidence in Behavioral Assessments of Your Product
11:00 am Focusing on Controllable Aspects of the Process to Minimize Effects of Biological Variability
Synopsis
- Understanding biological variability and patient history to overcome bottlenecks
- Benchmarking the most important attributes to quantify in cell based assays
- Minimizing environmental variability to increase confidence in your functional assessments of your product
11:30 am Developing Documentary Standards for Cell Based Assays to Provide Clear Guidelines and Harmonize Analytical Development
Synopsis
- Discussing measurement methods to accurately capture cell populations
- Understanding statistical methods to establish level of acceptable deviation
- Developing fixed cell materials for cell counting to reduce variability
12:00 pm Panel: How Do Characterization Approaches Differ Between Cell Types to Manage Complexity in Cell Differences
Synopsis
- Taking learnings from CAR-T to inform product characterization
- Optimizing analytical development for Gamma Delta, NK and iPSC derived products
- Determining the technologies required for automation and high-throughput characterization of different cell types
12:30 pm Lunch & Networking Break
1:29 pm
Improving Vein-to-Vein Time to Expedite Product Release & Align Analytical Development
1:30 pm Developing Rapid Analytics to Speed Up Turnaround Time for Sterility Testing
Synopsis
- Exploring how to move towards a more unified approach to sterility assessment
- Focusing on best practices for approaching meaningful sterility testing
- Looking at validating novel technologies, beyond cell growth for rapid detection and quick product release
2:00 pm Reviewing the Hurdles of Shortening Sterility Tests
Synopsis
- Exploring different rapid methods to understand their strengths and weaknesses
- Working with international regulatory bodies to align sterility tests with expectations
- Developing a novel, improved method for sterility testing according to pharmacopeia recommendations
2:30 pm Afternoon Networking Break
3:00 pm Roundtable: Discussing Analytical Life Cycle Management: Refining Your Process to Improve Efficiency
Synopsis
- Reviewing process development to identify necessary assays for more efficient processing
- Translating research protocols to industrial processes for smoother tech transfer
- Discussing key differences to developing analytical suites with autologous and allogeneic products
3:30 pm Collecting Functional Data for Meaningful Product & Process Characterization to Better Understand Cell Behavior
Synopsis
- Leveraging technical understanding of underlying mechanism of action to guide functional assay development
- Discussing the pros & cons of cell counting assays as measurements of functionality
- Exploring the potential of dilution dyes to give a more holistic view of functionality