Pre-Conference Manufacturing Focus Day
Tuesday, November 18
8:30 am Morning Coffee & Registration
Breaking the Scale Barrier Through Smart Scale Up vs Scale Out Strategies to Accelerate Late-Stage Success & Global Personalized Vaccine Access
9:00 am Scaling What’s Never Been Scaled: Lessons Learned From Building Late- Stage Manufacturing Readiness for Global PCV Trials
Synopsis
• How to design a scalable, modular manufacturing model to enable Phase II/III execution without overcommitting pre-commercial – including lessons from scaledown modeling to simulate future bottlenecks
• Strategic considerations in platform selection and core workflow standardization to support repeatability, reduce cost, and accelerate late-stage development
• Lessons from early investments in future-proofing critical processes – minimizing tech transfer complexity and enabling global trial expansion and real-world access
9:30 am Roundtable Discussion: Defining Quality Control Strategies That Support Speed, Compliance & Global Trial Execution for Personalized Vaccines
Synopsis
• Defining scalable QC frameworks for PCVs by identifying which release assays reduce redundancy, batch release time, and regulatory rework at Phase II and beyond
• Applying risk-based release strategies in bespoke manufacturing workflows to enable faster, compliant release of low-volume batches
• Designing digital QA systems early on to support faster QP release as batch volumes increase
10:30 am Morning Break
Benchmarking the Clock: Understanding the Rate-Limiting Steps Across Personalized Vaccine Manufacturing to Reach Best-in-Class Turnaround Time & Maintain Needle-to-Needle Speed
11:00 am What It Takes to Hit the 30-Day Turnaround: Optimizing the Manufacturing Workflow for mRNA Based PCVs to Deliver Rapid & Regulator-Ready Batches
Synopsis
• Streamlining mRNA manufacturing workflows to reduce IVT, LNP, Purification cycle time, and manual intervention
• Optimizing Phase II manufacturing operations to support a smooth transition to latestage readiness with improved repeatability, regulatory alignment, and trial scalability
• Operationalizing real-time analytics, digital batch release, and platform-based regulatory strategies across end-to-end manufacturing
11:30 am Achieving Sub-3-Week PCV Manufacturing: Leveraging Biopsy Timing & Dendritic Cell Delivery to Eliminate Bottlenecks & Improve Access
Synopsis
• Coordinating tumor biopsy with standard-of-care procedures to streamline sample collection and preserve cell viability
• Using biologically driven antigen selection and dendritic cell delivery to bypass lengthy genomic prediction and adjuvant formulation
• Reducing turnaround time to under 3 weeks and costs below $10K to improve patient access
12:00 pm Developing a Practical & Scalable Autologous Vaccine Manufacturing Platform Using Whole Tumor Cells to Enable Real-World Application of Personalized Immunotherapy
Synopsis
• Adapting blood sterilization technology to manufacture metabolically active, nonreplicating tumor cells for autologous immunotherapy to simplify production and preserve immunogenic function
• Manufacturing workflow from tumor resection to reinjection – streamlining critical steps to reduce turnaround time and improve reproducibility
• Advancing toward clinical translation in relapsed ovarian cancer to demonstrate realworld applicability and pave the way for broader tumor indications
12:30 pm Lunch Break
Building the Self-Driving Factory: Harnessing Automation, In-Process Intelligence, & Digital Infrastructure to Facilitate Smart Personalized Vaccine Manufacturing
1:30 pm From Bioinformatics to the Bedside: Verifying Neoantigens & Tracking Vaccine Response Through Blood-Based Immune Analytics
Synopsis
• Validating T cell responses from blood to reduce target selection risk and eliminate non-functional epitopes from manufacturing
• Mapping TCR dynamics longitudinally to guide dosing decisions and build confidence in immune activity before clinical endpoints
• Pairing bioinformatics with functional immunology to prove the mechanism of action and support regulatory acceptance of personalized therapies
• Using early immune analytics to de-risk trial failure and accelerate iteration across both vaccine design and manufacturing batches
2:30 pm Manufacturing of an Individualized Cancer Vaccine based on Modified Vaccinia Ankara (MVA) Viral Platform
Synopsis
• Developing the viral-based individualized neoantigen therapeutic vaccine platform myvac from phase I clinical trial to a robust Manufacturing
• Regulatory considerations for personalized cancer vaccines