Conference Day One
Tuesday, December 2
7:00 am Morning Registration & Coffee
7:30 am Chair’s Opening Remarks
Driving Analytical Innovation & Regulatory Dialogues to Advance Cell Therapies
8:00 am Industry Leaders Fireside Chat: Shaping the Future of Analytical Development in Cell Therapy by Responding to Evolving Regulations & Investing in Innovation
Synopsis
An interactive panel discussion from the industry leaders of the field to set the scene on the cell therapy analytical development space.
Ask your questions live to understand the experts’ thoughts on key topics, including:
- The implications of recent changes in the FDA and regulations to the analytical development and cell therapy field as a whole
- Recent innovations in analytical methods and platforms that are advancing the field
- What critical hurdles remain in developing, transferring, and validating assays for living cell products?
9:00 am Building GMP-Ready Assays from Day One – Analytical Planning for Success
Synopsis
- Employ analytical planning to give yourself a head start: Defining analytical assays with a mind of scalability and translation before assay work begins aligns teams around clear performance goals. A shared blueprint prevents rework and ensures data are validation-ready from the start.
- Standardize early: Setting hardware, software, and reagent choices early removes variability. Smart Gain and StainExpress™ technologies make multi-site transfer seamless and can cut weeks from qualification.
- Define a team as your analytical bridge to GMP: A defined team translates R&D knowledge into GMP execution through risk-based design and complete SOPs. A structured approach can significantly shorten IND preparation.
9:30 am Bringing Clarity to Regulatory Interactions: Proactive Strategies & FDA Updates to Align Analytical Expectations
Synopsis
- Gain insight into recent FDA leadership and organizational changes, as well as how they influence evolving policy development and its practical enforcement in analytical development
- Explore tactics for presenting data and negotiating assay specifications that reflect real-world manufacturing capabilities and clinical realities
- Learn how early, well-structured engagement with regulators can help align on assay expectations, minimize rework, and support smoother progression through pivotal milestones
10:00 am Lessons Learned in CAR-T Cell Product Potency Measurement: A Cross-Functional Investigation & the Importance of Partnership
Synopsis
- Cross-functional investigation uncovered unexpected factors affecting CAR-T cell potency measurement, demonstrating the power of partnership between Autolus and Agilent
- Rigorous analytical troubleshooting and collaboration led to a breakthrough, restoring reliability and reproducibility in potency assays for cell therapy development
- Key lessons emphasize the importance of open communication, experimental rigor, and teamwork in overcoming complex QC challenges in advanced therapies
10:30 am Morning Break & Speed Networking
Early-Stage Analytical Development
Aligning Assay Design & Development with Long-Term Cell Therapy Goals
Track Chair
11:30 am Panel Discussion: Key Considerations to Future Proof Analytical Development Efforts
Synopsis
- How can we ensure sufficient sample retention early to support unforeseen testing and regulatory requirements
- Manage the underestimated complexity and time demands of cell-based and potency assay development
- What are some opportunities for platforming assays to reduce duplication and streamline multi-program assay workflows?
12:00 pm Vitality as a New Standard: Predictive, Label-Free Cellular PAT for Improved Cell Therapy Quality and Consistency
Synopsis
- Laser Force Cytology™ (LFC™): A new frontier in single-cell analytics Learn how LFC™ enables real-time, label-free measurement of cell vitality, stress response, and functional potential—offering a deeper, earlier view into therapeutic relevance than traditional viability assays
- Radiance® as a cellular PAT platform across the product lifecycle: See how Radiance® supports process analytical technology (PAT) from cell bank qualification to in-process monitoring and QC release, with actionable metrics that track phenotypic shifts and performance in real time
- Predictive vitality metrics for potency assurance and regulatory confidence: Discover how early functional insights correlate with downstream potency, enabling proactive quality control, reduced cost of goods, and stronger alignment with evolving regulatory expectations
Late-Stage Analytical Development
Unifying Assay Validation to Support Reliable & Regulatory-Ready Products
11:30 am Standards & Workflows to Enhance Cell Characterization Analytics & Advance Product Success
Synopsis
- Leverage robust experimental designs and analytical tools that support analytical integrity from early optimization to commercial scale-up
- Implement consistent workflows and platform-agnostic reference standards to overcome inconsistencies in product characterization across the manufacturing process
- Apply the principles of international documentary standards to cell therapy applications
12:00 pm From Collection to Release: Standardizing flow cytometry across leukapheresis collection centers and cell therapy development and manufacturing sites
Synopsis
- Flow cytometry immunophenotyping traditionally involves a complex, laborious workflow and can exhibit variability rooted in sample handling, reagent formulation, voltage calibration, compensation for spectral spillover in non-target channels, and subjective data analysis.
- This talk showcases how the Accellix Platform standardizes and automates each step in this workflow to provide a simple, rapid solution with minimal process variability and objective, algorithm-based cell subset classification and reporting.
- Updated automated analysis software now enables operators to run multiple algorithms tailored for specific sample types, including Streck CD-Chex Plus reference control material. Combining control material with standardized assays and analysis can harmonize cell phenotyping across labs and throughout the cycle of blood collection, process and analytical development, and cell therapy manufacturing.
12:30 pm Lunch Break & Networking
1:30 pm Unique Solutions for Functional Characterization of Engineered T-cells
Synopsis
- CAR Dextramer reagents for quality control release testing and measurement of cell persistency
- Antigen-specific T-cell activating scaffolds – simplifying potency assays
1:40 pm Navigating Genomic & Functional Characterization in Gene-Edited Cell Therapies
Synopsis
- Examine assay strategies to confirm both the presence of edits and preservation of cell function post-engineering
- Review real-world approaches for correlating genomic modifications with therapeutic impact using robust analytical endpoints
2:10 pm Interactive Roundtable Discussion: Designing Scalable Assays from Day One for Seamless Late-Stage Success
Synopsis
- Participate in an interactive exercise to identify early assay design decisions that can either streamline or stall future tech transfer and commercialization
- Explore real-world trade-offs around control complexity, reagent burden, and validation readiness
- Collaborate with peers to define best practices for designing assays that scale reliably across sites, platforms, and phases
1:30 pm Addressing Comparability and Regulatory QC Assays Through Multi-Modal Single-Cell Analysis
Synopsis
- CAR-T therapies (both autologous and allogeneic) are currently experiencing headwinds, and a major issue is sufficient analytical characterization to capture CQAs in a uniform and consistently reliable, rapid manner
- Regulatory and QC endpoints are coming under increased scrutiny, while patients are endlessly waiting for these therapies to be democratized and accessible
- This presentation will address how heterogeneity confounds these complexities, and how some industry entities are addressing multiple CQAs (transduction/VCN, dynamic cell fitness, allogeneic cell gene editing, genetic stability, and comparability) directly by measuring all these attributes at the single-cell level, simultaneously, with a single assay that is GxP-deployable with minimal CVs and consideration for 21CFR Part 11 compliance, while also satisfying ICH Q6B guidance
1:40 pm Strategic Assay Selection for Clinical Phases & Beyond
Synopsis
- Advancing flow cytometry and ddPCR from RUO to GMP to ensure assay robustness across development stages
- Differentiating target and off-target effects to meet regulatory expectations and strengthen product reliability
2:10 pm Late-Stage Assay Validation Strategies to Ensure Regulatory Alignment & Commercial Readiness
Synopsis
- Learn how to transition qualified release assays to fully validated methods that meet pivotal and commercial expectations
- Explore key validation criteria robustness, specificity, reproducibility and how to meet them under tight timelines
- Understand how assay maturity and early planning can reduce downstream risks during PPQ and commercialization
2:40 pm Afternoon Break & Poster Session
Strengthening Team Alignment to Transfer Complex Assays with Confidence
3:30 pm Lessons Learned from Cross-Team & Multi-Site Collaboration to Improve Assay Transfer & Scalability
Synopsis
- Assay design decisions, including control selection and technology, greatly affect transfer success and scalability across diverse teams and locations
- Effective strategies to reduce reagent usage help ensure consistent assay performance and comparability across multiple sites
- Real-world insights from navigating collaboration between analytical development and quality control teams reveal key approaches to minimize late-phase challenges and enhance smooth tech transfers
4:00 pm Case Study: Strategy for Seamless Assay Transfer Between Internal & External Teams for Reliable Analytical Results
Synopsis
- Approaches to making implicit knowledge explicit, including hands-on training and site visits, to overcome barriers in transferring complex assays, especially bioassays and cell-based methods
- How to improve alignment and communication between teams to distinguish assay variability from true process changes, ensuring confidence in analytical data
- Best practices for planning and resource management to facilitate smooth assay transfer and reduce troubleshooting time
4:30 pm End of Conference Day One
5:00 pm Drinks Reception
Synopsis
Raise a glass to great ideas and new connections! Join us for informal networking following the day’s sessions.