Conference Day Two
Wednesday, December 3
7:30 am Morning Check-In & Coffee
Innovative Solutions & Real-World Insights to Achieving Reliable & Timely Product Release
8:30 am Panel Discussion: Breaking Bottlenecks in Sterility & Safety Testing for Faster, More Reliable Cell Therapy Release
Synopsis
- Identify key release challenges, from lengthy sterility timelines to product-specific test compatibility, that delay patient access
- Compare rapid sterility and mycoplasma testing technologies, what is working, what is not, and how to validate them for your product
- Review regulatory hurdles and best practices for convincing authorities to accept novel test methods
9:30 am Interpreting the New US Pharmacopoeia Guidance for Sterility & Microbial Testing in Cell Therapy
Synopsis
- Understand the new USP <72> (respiration methods) and <73> (ATP Bioluminescence) chapter requirements for sterility testing of short-life products, official August 1, 2025
- Gain insight into the revised USP <1071> (rapid microbial tests for release of sterile short-life products) and timeline for the USP <77> chapter (mycoplasma release testing via molecular methods)
10:00 am Case Study: Accelerating Sterility Testing with Validated Alternatives for Rapid Product Release
Synopsis
- Experience validating a sterility method to support a seven-day turnaround time for product release, sharing lessons learned, challenges encountered, and key considerations for integrating rapid methods into GMP environments
- Highlights from the implementation of a rapid mycoplasma test that delivered results within one day
- Explore how thoughtful sampling time points and clear guidance can streamline rapid testing workflows and support consistent product quality
10:30 am Morning Break & Networking
Early-Stage Analytical Development
Integrating Biology & Analytics into First Potency Assays
11:30 am Building a Potency Assay Matrix for Logic-Gated CAR-T Programs Advancing Towards Clinical Validation
Synopsis
- Design a multi-assay approach to measure engagerdependent CAR activation through cytotoxicity and IFN-y secretion
- Leverage early Phase 1 data and FDA guidance to correlate in vitro functional readouts with therapeutic intent
- Establish platform assays to support regulatory submission and long-term quality control strategy for site-directed CAR-T therapies
12:00 pm Characterizing Cell Therapy Products with Potency Assays in Early Development
Synopsis
- Explore the use a matrix of assays including IFN-y, cytotoxicity and cytokine panels
- Use surrogate markers, functional outputs, and in vitro models to establish early correlation with intended therapeutic effect
Late-Stage Analytical Development
Aligning Late-Stage Method Changes with Regulatory Confidence & Operational Readiness
11:30 am Lessons Learned in Navigating Late-Stage Changes in Analytical Methods
Synopsis
- Share lessons learned from supporting quality control in latestage and commercial programs
- The role of analytical development in comparability planning and regulatory engagement when making changes in late commercialization and post BLA
12:00 pm Panel Discussion: Balancing Risk & Benefit When Making Late-Stage Analytical Changes
Synopsis
- How to assess the scientific, regulatory, and operational risks of modifying assays or specifications after pivotal trials begin
- When is it worth changing a method late-stage and what data is needed to justify the decision to regulators and internal teams?
- Best practices for building a comparability and bridging strategy that supports product integrity without delaying timelines
12:30 pm Lunch Break & Networking
Developing Novel Tools to Improve Product Characterization & Streamline the Path to Clinic
1:30 pm Perspectives on PCR-based Cellular Kinetics & Biodistribution Assessment
Synopsis
- The gap in the current regulatory guidance and the emerging state-of-the-art adoptive cell therapies
- Discuss a fit-for-purpose approach to characterize the cellular kinetics and biodistribution
2:00 pm Maximizing Early Insights Using Immunoassays & Spectral Flow Cytometry to Guide Smarter Analytical Strategy for Product Specification & Biomarker Studies
Synopsis
- Learn how early characterization supports data-driven assay selection and flexible specification setting ahead of validation
- Discover how spectral flow enables broader marker panels to extract maximum data from limited material during early development
- Understand how this upfront investment streamlines latestage refinement and regulatory alignment
Translating Clinical Outcomes into Stronger Potency Assays & Smarter Decisions
1:30 pm Defining & Demonstrating Potency in Stem Cell Based Regenerative Therapies for Vision Restoration
Synopsis
- Explore how to link cell characteristics with mechanisms of tissue repair and functional outcomes in macular degeneration
- Identifying measurable attributes that correlate with therapeutic potential in stem cell derived retinal pigmented epithelium cells
- Design release assays that reflect regenerative capacity and support consistent, phase-appropriate product characterization
2:00 pm Roundtable Discussion: De-Risking Commercial Success by Validating Potency Assays for Robust, Reproducible Results
Synopsis
- Map out a step-by-step validation pathway that builds regulatory confidence while maintaining functional relevance
- Co-create a checklist of best practices to validate potency assays across sites, analysts, and lots for smoother approval
2:30 pm Afternoon Break & Networking
Building Robust & Scalable Analytical Systems Amid Operational Constraints
3:00 pm Enhanced, Automated & Integrated Analytical Control Strategy & Execution Process for Autologous Cell Therapies
Synopsis
- Illustrate how a fully integrated analytical control strategy supports consistency and compliance from development through to commercialization
- Share case studies that demonstrate how proportioning allocations for variation and bias improves control over critical assay elements
- Highlight methods to track and manage analytical variability effectively across development, tech transfer, and commercial operations
3:30 pm Reducing Quality Control Costs in Cell Therapy to Achieve Smarter Assays, Leaner Workflows & Sustainable Strategies
Synopsis
- Discuss the benefits of assay miniaturization and simplification to lower material requirements and support more scalable, cost-effective testing
- Explore models for executing quality control including decentralization, outsourcing, and automation that reduces burden across both autologous and allogeneic workflows