CASSS Sharing Science Solutions CGTP Summit 2026 Cell and Gene Therapy Products Symposium 2026

The CASSS CGTP Summit and Cell and Gene Therapy Products Symposium 2026 examine how manufacturing, analytical development, quality, and regulatory strategy support advanced therapies. The June 8 summit focused on specifications, followed by the June 9–11 symposium in Rockville, Maryland. The supplied topics span gene editing, CAR-T therapies, mRNA, viral vectors, process qualification, potency testing, and comparability across manufacturing changes. Panels and case studies also consider prior knowledge, global regulatory pathways, and practical constraints in small-batch development. This material is relevant to CMC, analytical, process-development, quality, and regulatory professionals working on cell and gene therapy programs.

Program structure: The one-day CGTP Summit and the subsequent 2.5-day symposium were distinct programs at the Bethesda North Marriott Hotel & Conference Center, Rockville, Maryland. Agenda entries, including panels and roundtables, do not confirm complete recording coverage.

Learning Objectives

• Navigate CMC considerations and develop accelerated strategies for CRISPR, next-generation technologies, and in vivo epigenome editing.
• Design and execute practical Process Performance Qualification (PPQ) and validation strategies for complex cell and gene therapy programs.
• Establish phase-appropriate specifications and conduct rigorous analytical comparability analyses across multiple process and manufacturing changes.
• Optimize the manufacturing of mRNA and viral vectors while deploying advanced analytical characterizations such as mass photometry and NGS-based methods.
• Understand global regulatory perspectives, ICH harmonization efforts, and strategic roadmaps for driving concurrent US and EU approvals for gene therapies.

Topics

• A Quantitative Nuclear Translocation Assay for the Functional Characterization of Recombinant AAV

• Adoption of Synthetic Cell Mimics Enable Accelerated Method Transfer and PPQ

• Advancing Global Submissions Through a One Dossier Operating Model Concept, Implementation and Early Outcomes

• Adventures in Making Extreme mRNA Molecules

• Between Scylla and Charybdis Navigating Specification Setting for Rare and Ultra Rare Disease Programs

• Breakfast Chat – FDA Pilot Program CDRP

• CASSS Welcome CGTP 2026 Introduction / CASSS Welcome CGTP Summit 2026 Introduction

• Cell & Gene Therapy Discussion Group (CGTDG)

• CGTP 2026 Scientific Program / CGTP 2026 Summary Infographic

• Closing Remarks and Invitation to CGTP 2027 / Closing Remarks Invitation to CGTP Summit 2027

• CMC Considerations for CRISPR and Next-Gen Technologies Including ElevateBio’s LETI-101 as a Case Study

• Considerations for Leveraging Prior Knowledge for Cell and Gene Therapy Products

• Cost Drivers (in CMC)

• Current Status of Regenerative Medical Products in Japan

• Designing a Modular CMC Platform for Lentiviral Gene Therapies

• Developing First-in-Class In Vivo Epigenome Editing for Chronic Hepatitis B Accelerated CMC Development Strategies

• Development of a GMP-compliant Mass Photometry Platform Method for AAV Capsid Population Analysis

• Development of an NGS-Based Method for Characterization of gRNA Sequence Impurities

• Development of an Off-Target Strategy for a Novel Small Nuclease

• Development of Phase Appropriate Specifications

• Driving Concurrent US and EU Approvals for Gene Therapies Using a Reg-CMC Roadmap

• Early Phase vs. Late Phase Comparability Analysis After CMC Changes

• Evergreen Specification Setting Practices

• Facilitating the Transition to Late-Phase Gene Therapy Production Presented by Catalent Inc. / Facilitating the Transition to Late-Stage Gene Therapy Manufacturing

• From Insight to Specification Defining which Assays to Place on Release vs Characterization in mRNA Therapeutics

• From Molecule to Function Holistic Control Strategies for CAR T Starting Materials

• Holistic Thinking for PPQ Strategy Lessons Learned and Future Opportunities

• Host Cell Protein Analytics and Viral Vector Manufacturing for Cell and Gene Therapies Presented by Cygnus Technologies LLC

• How Are We Maximizing The Leveraging Of Prior Knowledge And Platform Processes

• How Has AI Changed the Way We Work What Role Will AI and ML Play in Personalized CellGene Therapies

• Keynote Presentation – From Innovation to Translation to Patients The Future of Genetically Engineered CAR T Cell Therapies

• Life CycleAligned Specifications Ensuring Quality and Consistency in Cell and Gene Therapy Development

• Lunch with the Experts CDMO Insights on Reducing COGM for CGT Products

• Manufacturing Changes and Comparability for Cell and Gene Therapy Products

• Manufacturing of mRNA by Fed-Batch in Vitro Transcription Optimization of Production Costs, Space-Time Yield, and Product Quality

• Modeling Strategies to Accelerate and De-Risk Viral Vector Development

• Navigating the “DS vs. Critical Component” Continuum for Gene Editing Tools Lessons from Autologous Cell Therapy Program Lifecycle Management

• Non-traditional Approaches to Comparability

• Nontraditional Process Validation Approaches

• Parallel Session 2 Panel Discussion Leveraging Prior Knowledge in Early Development of ATMPs

• Parallel Session 3 Panel Discussion Characterization and Quality Expectations for mRNA in Various Applications

• Parallel Session 5 Panel Discussion – Innovative Process Performance Qualification Strategies Supporting Accelerated Programs

• Parallel Session 6 Panel Discussion – Control Strategies for Gene Editing Across Platforms

• Plasmid-Free mRNA Synthesis on a Reusable Solid-Phase IVT Platform

• Plenary Session 1 Panel Discussion – Navigating Comparability Challenges in Cell and Gene Therapy Development

• Plenary Session 4 Panel Discussion – Gene and Epigenome Editing Mechanisms Driving Early-Phase Therapies

• Plenary Session 7 – Fireside Chat ICH Harmonization efforts for ATMPs

• Plenary Session 8 Panel Discussion – Next-Generation RNA Modalities CMC and Regulatory Strategies for Clinical Translation

• Plenary Session 9 – Global Regulatory Panel

• Poster Talks Panel Session 1 & 2

• PPQ Under Pressure Designing Practical Validation Strategies for CGT Programs

• PPQ-As-You-Go Accumulating CMC Validation Evidence in Step with Clinical Data in Rare Genetic Disease Programs

• Progressive Analytical Comparability Strategy for an Autologous CAR-T Cell Therapy Product Across Multiple Process Changes and Manufacturing

• Recommendations With Regard To Future ATMP Related Guidelines Output From Cell & Gene Therapy Discussion Group (CGTDG)

• Regulatory Perspectives on Establishing Specifications for Cell and Gene Therapy Products From Speculation to Specification

• Revamp, Replace, or Revolutionize Strategic Decisions in Potency Assay Evolution through Research and CMC

• RiskBased Analytical Comparability for am AAV Gene Therapy After an Early Manufacturing Site Change

• Session I Panel Discussion Challenges for ATMP Specifications – Part 1

• Session II Panel Discussion Challenges for ATMP Specifications – Part 2

• Session III Considerations When Setting Specifications for Autologous CAR T-cell Products

• Session IV Global Regulatory Panel on Specifications

• Target Product Profiles and Quality Target Product Profiles Product Development with the End in Mind

• Unorthodox Approaches to Stability Programs for Small Batch-size Cell and Gene Therapies

• What are the Most Critical Bottlenecks in CGT Manufacturing, and How Are We Solving Them

File scope: This purchase covers the educational files offered by MedicalAmboss. Event attendance, publisher-platform access, accounts, memberships, and publisher-hosted extras are not included.