Explore the Agenda
8:00 am Check-In, Coffee & Light Breakfast
8:55 am Chair’s Opening Remarks
Implementing Scalable DNA Manufacturing & Supply Strategies to Ensure Reliable & Accelerated Therapeutic Development
9:00 am Ensuring Supply Chain Robustness Through Risk Assessment & Multi- Sourcing Strategies
- Managing enzyme stability, shelf-life mismatches, and plasmid production variability to ensure consistent quality and scalability
- Navigating raw material constraints with limited GMP-grade enzyme suppliers and critical sourcing strategies
- Applying risk assessment tools such as FMEA and ICH-aligned frameworks to identify vulnerabilities, qualify suppliers, and establish multi-sourcing strategies for critical raw materials and GMP-grade enzymes
9:30 am Session Reserved for Purilogics (Donaldson)
9:40 am Bridging Small & Medium-Scale DNA Production: Practical Strategies for Scalable Manufacturing
- Plasmid manufacturing scale-up case study: strategy and lessons learned
- Value of in-process testing within development plan to build a more robust, scalable process
- Practical considerations to enable rapid development within budget
10:10 am Roundtable Discussion: Process Economics in DNA Manufacturing: Clinical vs. Commercial Perspectives
- Distinguishing pre-clinical and clinical-stage manufacturing (“quick and dirty”) vs commercial production (cost-efficient, scalable, validated)
- Cost of goods analysis: when is cost reduction critical, and when can it be deprioritized?
- Impact of company size: regulatory trust in large pharma vs. hurdles faced by small biotechs
- Economic implications of synthetic DNA adoption for individualized vs. largepopulation therapies
10:45 am Morning Break & Refreshments
Applying Advanced DNA Analytics & Innovative Assays to Characterize DNA & Ensure Quality for Optimized Therapeutic Devel-opment
11:15 am Roundtable Discussion: Sequencing Secrets: Evaluating Advanced Sequencing & Error Analysis to Assess DNA Fidelity
- Balancing between long-read sequencing’s insights into complex genomic regions and short-read sequencing’s high-throughput coverage to ensure holistic plasmid analysis
- Limitations of current accuracy measurement traditional methods
- Comparing Sanger and next-generation sequencing for identity verification, addressing gray areas in platform choice (Illumina, Nanopore, PacBio) and regulatory implications
- Uncovering the need for industry standards and regulatory guidance to define acceptable accuracy
12:00 pm Leveraging Advanced QbD Analytics to Define CQAs & Improve Plasmid DNA Process Robustness
- Define and control critical quality attributes for plasmid DNA, ensuring consistency, potency, and purity throughout development and scale-up
- Strengthen in-process controls and release testing frameworks to better link analytical outcomes with product performance and regulatory expectations
- Leverage advanced analytical tools for in-depth characterization
12:30 pm Lunch & Networking
12:30 pm Lunch & Networking
12:00 pm Leveraging Advanced QbD Analytics to Define CQAs & Improve Plasmid DNA Process Robustness
- Define and control critical quality attributes (CQAs) for plasmid DNA, ensuring consistency, potency, and purity throughout development and scale-up
- Strengthen in-process controls and release testing frameworks to better link analytical outcomes with product performance and regulatory expectations
- Leverage advanced analytical tools for in-depth characterization, enabling greater process understanding, comparability, and data-driven decision-making
Aligning Regulatory Expectations with Process Development & CMC Requirements to Enable Rapid Vaccine & Therapy Develop-ment
1:30 pm Building GMP-Ready DNA Manufacturing Infrastructure: Ensuring Quality, Consistency, &Scalability from R&D to Commercial Production
- Evolving facilities and quality systems as DNA transitions from a starting material to a GMP drug substance
- Developing technical depth and alignment across global, cross-functional teams to ensure consistent process performance
- Strengthening collaboration and knowledge exchange with CDMOs and suppliers to enable effective scale-up and seamless tech transfer from R&D to GMP
2:00 pm Roundtable Discussion: Residual DNA Guidelines Across Modalities: Unpack Challenges, Risk Assessments, & Regulatory Interactions
- Interpreting current regulatory thresholds (≤10 ng per dose, ≤200 bp fragment size) across gene therapy, vaccines, and monoclonal antibodies
- Practical strategies each field is using to reduce impurities and meet these requirements
- Risk assessment and regulatory dialogue: how companies are engaging with health authorities when thresholds cannot be fully met
2:45 pm Afternoon Break & Refreshments
Exploring Future Modalities & New Regulatory Territory While Advancing Innovation & Navigating Emerging Challenges
3:45 pm Using the USDA Prescription License Pathway as a Model to Quickly Administer Vaccines
- Discussing the need for a regulatory pathway built for speed and flexibility
- Highlighting approaches to accelerate plasmid cloning and amplification through streamlined workflows and scalable processes
- Unpacking strategies to quickly turn around QC testing timelines while maintaining quality and regulatory compliance
4:15 pm Manufacturing & Application of DNA as Building Materials for DNA Origami Nanoparticles
- Using DNA as structural building materials for DNA origami
- Assessing key considerations for DNA origami nanoparticle manufacturing
- Quantifying cargo loading on DNA origami nanoparticles