Day Two

• Implementing high-level automation strategies in parallel with ongoing clinical development to advance technology without impacting critical product approval timelines
• Transferring existing manual manufacturing platforms into fully automated end-to-end systems while managing comparability risks and maintaining process consistency
• Applying regulatory interaction lessons learned during automation implementation to navigate compliance requirements and avoid costly development timeline disruptions

• Integrating automation across manufacturing and analytical testing to reduce turnaround time and achieve competitive advantage in increasingly crowded therapeutic markets
• Scaling automated autologous production from an initial two to three patients per week to hundreds globally while maintaining reliability and meeting contractual delivery commitments
• Reducing the cost of goods from half a million dollars per patient lot to small fractions through comprehensive automation to ensure long-term commercial sustainability

• Accelerating process development by examining machine learning case studies demonstrating practical tools, data requirements, and measurable workflow improvements
• Improving manufacturing predictability by leveraging machine learning to predict donor variability impacts and identify patient-specific factors affecting product quality
• Strengthening predictive process control by integrating real-time monitoring and AI analytics into existing GMP systems with traceable data collection

• Selecting vendors with proven capability to scale support from early clinical phases through commercial launch and beyond
• Conducting comprehensive due diligence to evaluate vendor reliability, regulatory compliance, and long-term partnership potential amid evolving market complexities
• Collaborating with automation vendors early in product development to influence their pipelines and ensure tools meet specific biotechnology requirements

• Evaluate an integrated framework for optimizing cryopreservation of cell therapy products, combining advanced cryoformulation characterization with engineered controlled‑rate freezing processes for efficient freezing and scale up
• Understand how reduced‑DMSO and DMSO‑free formulations, along with precise ice‑nucleation and cooling‑rate strategies, improve post‑thaw viability, apoptosis profiles, and cellular fitness
• Review critical temperature‑handling limits based on intracellular glass‑transition behavior, ensuring safe storage and transport and robust clinical manufacturing of CAR‑T drug products

• Identifying which downstream process parameters can be modified versus fixed constraints inherent to cell therapy product profiles to focus optimization efforts effectively
• Evaluating existing downstream platform landscape including module features, pros and cons across different cell therapy situations to select best-fit technologies
• Implementing automation considerations at each development stage to enable seamless platform transitions and prevent costly impacts during commercial scale-up

• Initiating early product and process lifecycle mapping to identify optimal timing for changes while leveraging FDA guidelines emphasizing flexibility in early phases versus stringent late-stage expectations
• Implementing robust statistical justification strategies and collaborating with statisticians to overcome analytical challenges and support regulatory-compliant comparability assessments
• Applying risk management frameworks in stepwise approaches to tackle potential showstoppers early and facilitate smoother transitions throughout process development activities

This session is your opportunity to share your most pressing challenges, and work as a group to come up with solutions that you can implement right away. Each topic area will have two groups, and each group will have 30 minutes to discuss ways to overcome barriers. Groups will then share their findings with all attendees, giving you maximum exposure to new ideas!

Roundtable Discussion: Navigating Phase-Specific Regulatory Expectations to Align Process Development & Enable Seamless Commercial Progression

• Defining phase-appropriate characterization rigor, comparability strategies, and parameter lock timing to satisfy regulatory requirements while maintaining optimization flexibility

Roundtable Discussion: Defining In Vivo Cell Therapy Process Development Requirements & Comparing Manufacturing Paradigms to Traditional Ex Vivo Approaches

• Contrasting in vivo versus ex vivo cell therapy manufacturing workflows to identify unique process development challenges, including vector production and delivery systems

• Implementing proprietary expansion methods to scale unconventional gamma delta T cells from low starting numbers to over 100 billion cells while maintaining therapeutic phenotype and functional markers
• Establishing quality control processes using flow cytometry to characterize cells before and after expansion, ensuring potential activation and anti-tumor cytotoxicity exceeding 90 percent
• Investigating tumor microenvironment interactions and immune evasion mechanisms to optimize gamma delta T cell product quality and overcome exhaustion for consistent therapeutic efficacy

• Implementing early-stage process optimization strategies across cost, manufacturing complexity, and regulatory considerations to establish foundations for commercial viability
• Addressing critical decisions during early development that impact future scale-out capabilities, from producing 10 doses in phase one to thousands in commercial manufacturing
• Balancing multiple optimization workstreams, including out-of-spec reduction and process simplification during early phases to prevent costly late-stage manufacturing bottlenecks